Development of a paediatric-friendly formulation intended for the treatment of multi-drug resistant tuberculosis
- Authors: Nkomo, Jethro
- Date: 2018
- Subjects: Drugs -- Dosage , Pediatrics -- Formulae, receipts, prescriptions Multidrug-resistant tuberculosis -- South Africa Primary health care -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33660 , vital:32962
- Description: Children suffering from multidrug-resistant tuberculosis (MDR-TB) are treated with at least four drugs a day for at least twenty-four months. Approximately 25 000 - 32 000 children worldwide become infected with MDR-TB each year, yet there is a lack of adequate paediatric MDR-TB options for child-friendly dosage forms for the treatment of the condition. The available options are limited to manipulating different dosage forms intended for adults by means of breaking the tablets or otherwise, to deliver the drugs to children. This challenge that is faced by both health care professionals and caregivers subsequently poses drug quality, efficacy, and safety concerns to children being treated for MDR-TB. The objective of this study was to formulate a paediatric-friendly dosage form for the treatment of MDR-TB in children below the age of eight years. A fixed-dose combination (FDC) in form of a dispersible-tablet that contains two core drugs used in treatment of MDR-TB; levofloxacin and pyrazinamide, was developed. Quality by design principles was employed in developing the product. The systematic procedure ensures that quality is built into the product throughout the manufacturing process. It allows for identification of the critical quality attributes and modification of critical process parameters to lie within desired ranges. Preformulation studies were conducted on the active ingredients to investigate potential interactions and compatibility. Some of the analytical techniques employed in the process included an HPLC assay method that was developed to simultaneously separate levofloxacin and pyrazinamide, differential scanning calorimetry (DSC), infrared spectroscopy (IR), thermogravimetric analysis (TGA), and powder density studies. A direct compression tableting process was selected as the method of choice for product formulation. Active ingredients were blended with the excipients and compressed using tableting equipment to successfully produce FDC fast-disintegrating tablets containing 150 mg of levofloxacin and 300 mg pyrazinamide. The product quality was analysed and optimised using mathematical and statistical techniques such as response surface methodology (RSM) and ANOVA, to meet the required standards recommended by the United States Pharmacopoeia. The FDC dispersible tablet containing levofloxacin and pyrazinamide in the potential treatment of MDR-TB in children was successfully formulated, manufactured and evaluated. The tablet dosage form passed all the relevant quality criteria that governed the scope of this study and disintegrate in approximately 37 seconds when placed in water. It is generally a sizeable challenge to manufacture fixed-dose combination drug products due to physicochemical differences of various drugs, however, with adequate resources researchers may still find a way to formulate more child-friendly dosage forms for MDR-TB. This may lead to improved drug efficacy, reduced safety risks and decreased burden on caregivers and healthcare workers who must administer the treatment.
- Full Text:
- Date Issued: 2018
- Authors: Nkomo, Jethro
- Date: 2018
- Subjects: Drugs -- Dosage , Pediatrics -- Formulae, receipts, prescriptions Multidrug-resistant tuberculosis -- South Africa Primary health care -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33660 , vital:32962
- Description: Children suffering from multidrug-resistant tuberculosis (MDR-TB) are treated with at least four drugs a day for at least twenty-four months. Approximately 25 000 - 32 000 children worldwide become infected with MDR-TB each year, yet there is a lack of adequate paediatric MDR-TB options for child-friendly dosage forms for the treatment of the condition. The available options are limited to manipulating different dosage forms intended for adults by means of breaking the tablets or otherwise, to deliver the drugs to children. This challenge that is faced by both health care professionals and caregivers subsequently poses drug quality, efficacy, and safety concerns to children being treated for MDR-TB. The objective of this study was to formulate a paediatric-friendly dosage form for the treatment of MDR-TB in children below the age of eight years. A fixed-dose combination (FDC) in form of a dispersible-tablet that contains two core drugs used in treatment of MDR-TB; levofloxacin and pyrazinamide, was developed. Quality by design principles was employed in developing the product. The systematic procedure ensures that quality is built into the product throughout the manufacturing process. It allows for identification of the critical quality attributes and modification of critical process parameters to lie within desired ranges. Preformulation studies were conducted on the active ingredients to investigate potential interactions and compatibility. Some of the analytical techniques employed in the process included an HPLC assay method that was developed to simultaneously separate levofloxacin and pyrazinamide, differential scanning calorimetry (DSC), infrared spectroscopy (IR), thermogravimetric analysis (TGA), and powder density studies. A direct compression tableting process was selected as the method of choice for product formulation. Active ingredients were blended with the excipients and compressed using tableting equipment to successfully produce FDC fast-disintegrating tablets containing 150 mg of levofloxacin and 300 mg pyrazinamide. The product quality was analysed and optimised using mathematical and statistical techniques such as response surface methodology (RSM) and ANOVA, to meet the required standards recommended by the United States Pharmacopoeia. The FDC dispersible tablet containing levofloxacin and pyrazinamide in the potential treatment of MDR-TB in children was successfully formulated, manufactured and evaluated. The tablet dosage form passed all the relevant quality criteria that governed the scope of this study and disintegrate in approximately 37 seconds when placed in water. It is generally a sizeable challenge to manufacture fixed-dose combination drug products due to physicochemical differences of various drugs, however, with adequate resources researchers may still find a way to formulate more child-friendly dosage forms for MDR-TB. This may lead to improved drug efficacy, reduced safety risks and decreased burden on caregivers and healthcare workers who must administer the treatment.
- Full Text:
- Date Issued: 2018
Impact of dietary factors on drug adherence and the nutritional status of tuberculosis patients in the Nelson Mandela Bay Health District
- Authors: Human, Wieda
- Date: 2018
- Subjects: Patients -- Nutritional aspects -- South Africa -- Nelson Mandela Bay Municipality , Tuberculosis -- Patients -- Nutritional aspects -- South Africa -- Nelson Mandela Bay Municipality Drug-nutrient interactions Appetite -- Effect of drugs on
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/22265 , vital:29929
- Description: The prevalence of poor adherence by Tuberculosis (TB) patients to their drug regimens poses a major public health problem in South Africa. Many South Africans are the victims of poverty and unemployment and, as a result, may face food insecurity, hunger and have diets lacking diversity. Malnutrition is commonly noted in patients with TB. Poor immunity as a result of TB further compromises the nutritional status of the patient and thus the prognosis. Chronic hunger together with food insecurity and inadequate dietary diversity can lead to poor drug adherence amongst patients. This highlights the fact that dietary factors may pose a threat to TB drug adherence. There is limited information available regarding the impact of dietary factors on drug adherence and the nutritional status in patients with TB, especially in the Eastern Cape. This emphasises the need for more research focusing on the impact that dietary factors have on drug adherence and nutritional status of patients with TB from underprivileged areas. The aim of the study was to describe the impact of dietary factors on drug adherence and the nutritional status of patients with TB from underprivileged areas in the Nelson Mandela Bay Health District (NMBHD) in order to revise current guidelines to standardise the nutrition management in patients with TB who are initiated on treatment. A descriptive, cross-sectional study was conducted using a quantitative approach. Ethical approval was obtained from the Research Ethics Committee (NMU) and the Eastern Cape Department of Health Provincial Research Committee. All participants provided written, informed consent prior to participation. A representative sample was drawn from each of the three sub-districts in the NMBHD to include a total of 256 participants. The following clinics were randomly selected: Max Madlingozi, Tshangana, Soweto clinic (sub-district A), Laetitia Bam, Middle Street, Rosedale (sub-district B) while clinics in sub-district C included Korsten, Walmer, Gelvandale and Helenvale. The population for the study included patients with TB older than 18 years treated at these specific clinics. Patients with Drug- Resistant TB were excluded. A structured interview was conducted by the researcher and three fieldworkers to obtain information on socio-demographics, drug adherence, food insecurity and dietary diversity. Anthropometric measurements (weight and height) were also obtained to determine the nutritional status of participants. The majority of participants were male (59%; n=150). The mean age of participants was 35,03 years (SD=11.97). Of the total sample, 70% (n=179) reported being currently unemployed, while 59% of the total sample were also unemployed prior to TB diagnosis. Fifty percent of participants (n=127) were HIV co-infected, while only a marginal percentage (3%; n=7) had Diabetes Mellitus. Treatment adherence was considered 'good' as 94% (n=240) reported taking their TB treatment daily while 92% (n=121) reported taking their antiretroviral therapy (ART) daily. About a third (32%; n=81) of the total sample experienced low appetite, followed by nausea (21%; n=53) and vomiting (20%; n=50). A large percentage (48%; n=123) of participants experienced severe hunger. The mean individual dietary diversity score (DDS) for this sample was below 3 (2.81/9) and could be classified as being moderately diverse. Forty-three percent (n=110) had a low DDS of 2 or less food groups. Only 2% (n=5) had a high DDS of more than 7 food groups. A statistically significant association was found between employment status and food insecurity and poor DDS. Previous TB infection was also significantly associated with food insecurity and poor DDS. Although so many participants were food insecure, 74% (n=188) reported taking their TB treatment with food. Regarding substance use, 24% (n=88) consumed alcohol weekly, whereas 31% (n=80) of participants smoked cigarettes. The mean BMI value for males was 20.93 kg/m2 (SD=4.19) and for females at 20.91 kg/m2 (SD=5.10). However, 30% (n=76) had BMI values below 18.5 kg/m2 and 16% (n=40) had BMI values above 25 kg/m2. Majority of the participants (91%; n=233) had lost weight prior to data collection. Furthermore, 75% (n=175) reported having experienced involuntary weight loss in the preceding 3 months, while 17% (n=43) reported having lost more than 10% of their body weight in the last 3 months. Almost all participants reported taking their TB treatment as prescribed. However, the study results echo the findings of other studies that a large cohort of participants are currently unemployed and food insecure. Many participants were consuming monotonous diets, consisting primarily of starch with little vegetables and fruits. As a result, the nutritional status of the sample population was compromised. This sample also reflected unhealthy lifestyle habits which included substance use (alcohol and cigarette smoking). As so many participants self-reported adhering to TB treatment, it was challenging to determine the impact that dietary factors have on TB drug adherence. Government, NGO's and other private stakeholders should make nutrition a priority especially in vulnerable groups such as patients with TB. Dietitians and nutritionists should be involved in the care of all patients with TB by providing relevant nutrition counselling. Although malnourished patients with TB are currently receiving nutrition supplementation, the amount and sustainability thereof should be revised. Food gardens may further be a safety net against food insecurity, hunger and inadequate dietary diversity.
- Full Text:
- Date Issued: 2018
- Authors: Human, Wieda
- Date: 2018
- Subjects: Patients -- Nutritional aspects -- South Africa -- Nelson Mandela Bay Municipality , Tuberculosis -- Patients -- Nutritional aspects -- South Africa -- Nelson Mandela Bay Municipality Drug-nutrient interactions Appetite -- Effect of drugs on
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/22265 , vital:29929
- Description: The prevalence of poor adherence by Tuberculosis (TB) patients to their drug regimens poses a major public health problem in South Africa. Many South Africans are the victims of poverty and unemployment and, as a result, may face food insecurity, hunger and have diets lacking diversity. Malnutrition is commonly noted in patients with TB. Poor immunity as a result of TB further compromises the nutritional status of the patient and thus the prognosis. Chronic hunger together with food insecurity and inadequate dietary diversity can lead to poor drug adherence amongst patients. This highlights the fact that dietary factors may pose a threat to TB drug adherence. There is limited information available regarding the impact of dietary factors on drug adherence and the nutritional status in patients with TB, especially in the Eastern Cape. This emphasises the need for more research focusing on the impact that dietary factors have on drug adherence and nutritional status of patients with TB from underprivileged areas. The aim of the study was to describe the impact of dietary factors on drug adherence and the nutritional status of patients with TB from underprivileged areas in the Nelson Mandela Bay Health District (NMBHD) in order to revise current guidelines to standardise the nutrition management in patients with TB who are initiated on treatment. A descriptive, cross-sectional study was conducted using a quantitative approach. Ethical approval was obtained from the Research Ethics Committee (NMU) and the Eastern Cape Department of Health Provincial Research Committee. All participants provided written, informed consent prior to participation. A representative sample was drawn from each of the three sub-districts in the NMBHD to include a total of 256 participants. The following clinics were randomly selected: Max Madlingozi, Tshangana, Soweto clinic (sub-district A), Laetitia Bam, Middle Street, Rosedale (sub-district B) while clinics in sub-district C included Korsten, Walmer, Gelvandale and Helenvale. The population for the study included patients with TB older than 18 years treated at these specific clinics. Patients with Drug- Resistant TB were excluded. A structured interview was conducted by the researcher and three fieldworkers to obtain information on socio-demographics, drug adherence, food insecurity and dietary diversity. Anthropometric measurements (weight and height) were also obtained to determine the nutritional status of participants. The majority of participants were male (59%; n=150). The mean age of participants was 35,03 years (SD=11.97). Of the total sample, 70% (n=179) reported being currently unemployed, while 59% of the total sample were also unemployed prior to TB diagnosis. Fifty percent of participants (n=127) were HIV co-infected, while only a marginal percentage (3%; n=7) had Diabetes Mellitus. Treatment adherence was considered 'good' as 94% (n=240) reported taking their TB treatment daily while 92% (n=121) reported taking their antiretroviral therapy (ART) daily. About a third (32%; n=81) of the total sample experienced low appetite, followed by nausea (21%; n=53) and vomiting (20%; n=50). A large percentage (48%; n=123) of participants experienced severe hunger. The mean individual dietary diversity score (DDS) for this sample was below 3 (2.81/9) and could be classified as being moderately diverse. Forty-three percent (n=110) had a low DDS of 2 or less food groups. Only 2% (n=5) had a high DDS of more than 7 food groups. A statistically significant association was found between employment status and food insecurity and poor DDS. Previous TB infection was also significantly associated with food insecurity and poor DDS. Although so many participants were food insecure, 74% (n=188) reported taking their TB treatment with food. Regarding substance use, 24% (n=88) consumed alcohol weekly, whereas 31% (n=80) of participants smoked cigarettes. The mean BMI value for males was 20.93 kg/m2 (SD=4.19) and for females at 20.91 kg/m2 (SD=5.10). However, 30% (n=76) had BMI values below 18.5 kg/m2 and 16% (n=40) had BMI values above 25 kg/m2. Majority of the participants (91%; n=233) had lost weight prior to data collection. Furthermore, 75% (n=175) reported having experienced involuntary weight loss in the preceding 3 months, while 17% (n=43) reported having lost more than 10% of their body weight in the last 3 months. Almost all participants reported taking their TB treatment as prescribed. However, the study results echo the findings of other studies that a large cohort of participants are currently unemployed and food insecure. Many participants were consuming monotonous diets, consisting primarily of starch with little vegetables and fruits. As a result, the nutritional status of the sample population was compromised. This sample also reflected unhealthy lifestyle habits which included substance use (alcohol and cigarette smoking). As so many participants self-reported adhering to TB treatment, it was challenging to determine the impact that dietary factors have on TB drug adherence. Government, NGO's and other private stakeholders should make nutrition a priority especially in vulnerable groups such as patients with TB. Dietitians and nutritionists should be involved in the care of all patients with TB by providing relevant nutrition counselling. Although malnourished patients with TB are currently receiving nutrition supplementation, the amount and sustainability thereof should be revised. Food gardens may further be a safety net against food insecurity, hunger and inadequate dietary diversity.
- Full Text:
- Date Issued: 2018
Intake of salt and sugar in grade five learners at underprivileged schools in Port Elizabeth compared to the intake at underprivileged schools in Johannesburg
- Authors: Straub, Alycia
- Date: 2018
- Subjects: Children -- Nutrition -- South Africa -- Port Elizabeth , Children -- Nutrition -- South Africa -- Johannesburg , Hypertension , Obesity in children
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33261 , vital:32614
- Description: The literature clearly indicates that excessive amounts of salt and sugar, compared to the recommended amounts, are consumed by young children, leading to the earlier presentation of lifestyle diseases such as obesity, diabetes mellitus type 2 and hypertension (Lichtenstein et al., 2006; Grimes et al., 2013). The problem to address is that there is insufficient information available on the intake of sugar and salt in South African children, and more specifically in the Johannesburg and Port Elizabeth areas; this information is necessary to determine which prevention strategies should be developed. The aim of this study was to determine the current intake of salt and sugar of grade five learners at a sample of quintile three schools in Johannesburg and Port Elizabeth and to investigate whether there was a relationship between the sugar and salt intake and the BMI (kg/m2) and blood pressure (mmHg) of these learners. A baseline exploratory, quantitative, descriptive, cross-sectional study design was used. A non-random, convenient sampling method was used with a sample size of 220 consenting learners of Johannesburg and 350 of Port Elizabeth. A semi-quantitative adapted food frequency questionnaire was used to determine the current intake of salt and sugar in the learners. The data was analysed using the SPSS version 22 programme. Ethical clearance was obtained from the relevant bodies. The results were as follows: no significant differences were found between the frequency of consumption of any of the food items that were chosen to represent salt and sugar intake and blood pressure and BMI within either Johannesburg or Port Elizabeth. Therefore, no associations between salt and sugar intake and blood pressure and BMI were found within either area. When comparing the learners of Johannesburg with those in Port Elizabeth a few significant differences were found; mostly showing a weak association. However, there was a moderate association for sugar in tea/ coffee between the underweight and overweight/obese learners of Johannesburg compared to Port Elizabeth. Preferences, peer influence and food culture are suggested reasons for this significant difference. Recommendations of the study were the South African Food-based Dietary Guidelines “Use salt and foods high in salt sparingly” and “Use food and drinks that contain sugar sparingly and not between meals” should continue to be encouraged.
- Full Text:
- Date Issued: 2018
- Authors: Straub, Alycia
- Date: 2018
- Subjects: Children -- Nutrition -- South Africa -- Port Elizabeth , Children -- Nutrition -- South Africa -- Johannesburg , Hypertension , Obesity in children
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33261 , vital:32614
- Description: The literature clearly indicates that excessive amounts of salt and sugar, compared to the recommended amounts, are consumed by young children, leading to the earlier presentation of lifestyle diseases such as obesity, diabetes mellitus type 2 and hypertension (Lichtenstein et al., 2006; Grimes et al., 2013). The problem to address is that there is insufficient information available on the intake of sugar and salt in South African children, and more specifically in the Johannesburg and Port Elizabeth areas; this information is necessary to determine which prevention strategies should be developed. The aim of this study was to determine the current intake of salt and sugar of grade five learners at a sample of quintile three schools in Johannesburg and Port Elizabeth and to investigate whether there was a relationship between the sugar and salt intake and the BMI (kg/m2) and blood pressure (mmHg) of these learners. A baseline exploratory, quantitative, descriptive, cross-sectional study design was used. A non-random, convenient sampling method was used with a sample size of 220 consenting learners of Johannesburg and 350 of Port Elizabeth. A semi-quantitative adapted food frequency questionnaire was used to determine the current intake of salt and sugar in the learners. The data was analysed using the SPSS version 22 programme. Ethical clearance was obtained from the relevant bodies. The results were as follows: no significant differences were found between the frequency of consumption of any of the food items that were chosen to represent salt and sugar intake and blood pressure and BMI within either Johannesburg or Port Elizabeth. Therefore, no associations between salt and sugar intake and blood pressure and BMI were found within either area. When comparing the learners of Johannesburg with those in Port Elizabeth a few significant differences were found; mostly showing a weak association. However, there was a moderate association for sugar in tea/ coffee between the underweight and overweight/obese learners of Johannesburg compared to Port Elizabeth. Preferences, peer influence and food culture are suggested reasons for this significant difference. Recommendations of the study were the South African Food-based Dietary Guidelines “Use salt and foods high in salt sparingly” and “Use food and drinks that contain sugar sparingly and not between meals” should continue to be encouraged.
- Full Text:
- Date Issued: 2018
Weight gain in hospitalised low birth weight (LBW) premature infants receiving breast milk or breast milk with human milk fortifier in the Nelson Mandela Bay Health District
- Authors: Wicomb, Ra-eesa
- Date: 2018
- Subjects: Premature infants -- South Africa -- Nelson Mandela Bay Municipality , Birth weight, Low -- South Africa -- Nelson Mandela Bay Municipality Birth weight -- South Africa -- Nelson Mandela Bay Municipality Infants -- Nutrition Children -- Nutrition -- Research
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/23327 , vital:30529
- Description: Rationale: Worldwide, hospitals with premature units have one generalised objective, i.e. to achieve postnatal growth and body composition similar to that of a normal foetus of similar gestational age. Optimal nutrition leads to optimal neurodevelopment and breastfeeding (BF) is known as the golden standard for infant nutrition. Human breast milk (BM) has significant value for preterm and term infants and is of special benefit to HIV infected mothers. Maternal supplementation is provided as part of the standard protocol in certain hospitals in the Eastern Cape province to those mothers who breastfeed their low birth weight (LBW) infants after delivery. human milk fortifier (HMF) is a nutritional supplement that is added to expressed breast milk for feeding preterm infants in order to meet their high energy and protein needs and therefore supporting the recommended growth velocity of 10g/kg/day-15g/kg/day. Some hospitals within South Africa provide HMF to preterm infants as part of their standard nutritional protocol in order for the infant to gain weight if BM only failed to produce adequate results. To date, little to no South African studies support or discourage the use of HMF for LBW infants. This study aimed to describe the effect of maternal supplementation compared with breast milk with HMF, or a combination of maternal supplementation and breast milk with HMF, on growth velocity in hospitalised LBW premature infants within the Nelson Mandela Bay health district. The proposed study design followed a longitudinal, observational, descriptive study in a cohort of LBW infants. The study was analytical using quantitative empirical data. Study participants were selected, by using convenience sampling, at Dora Nginza Hospital, Zwide between October 2015 and August 2016 (ethics approval: EC_2016RP27_564). Quantitative data on anthropometric measurements was collected from study participants. Primary care givers provided written informed consent. Registered nurses were trained and performed anthropometrical measurements according to standardised methods. A structured questionnaire was completed by the principal reasarcher as a source of data collection. Numerical data was described using means and standard deviations. Chi squares were used to describe the associations between maternal risk factors and birth weight outcomes. ANOVA was used to determine the relationship between growth velocity and the various supplementation groups. A sample size of 91 LBW preterm infants and mother pairs were entered into this study. The majority of mothers, 64% (n=58) fell in the age category of 20-35 years old. Of the total maternal sample (n=88), 35% (n=31) were classified in the at risk age category, i.e. <20years old and >36years old. Out of the total infant sample (n=91), 65% (n=59) was classified as VLBW, 22% was LBW and 22% (n=20) was ELBW. No statistically significant association was found between infant growth velocity and maternal risk factors. The group receiving BM with HMF had a mean growth velocity of 19.75 g/kg/day (SD=6.45) that was statistically significantly (p<0.05) more than the other groups. The maternal supplementation only group and the maternal supplementation and BM fortification group showed mean growth velocities of 12.26 g/kg/day (SD=5.41) and 12.29 g/kg/day (SD=6.97) respectively. A post hoc test was done between growth velocity in the supplementated groups and the length of hospital stay. These results reveal that the group receiving BM with HMF had a significantly (p<0.05) shorter mean length of hospital stay of 11.29 days (SD=7.02), compared with the group on the combination of maternal supplementation and BM with HMF. In this study, infants receiving HMF with BM showed the highest growth velocity with the shortest hospital stay before discharge. In this group, infants were already receiving an adequate BM intake of 150-180 ml/kg/day prior to participation in the study. This meant that the HMF group consisted of more stable preterm infants compared to the rest of the supplementated groups. However, a large proportion of participants in the maternal supplementation group also showed adequate to good growth velocity. The researcher recommends the implementation of maternal supplementation only, as standard of care for all hospitalised lactating women. Furthermore, timeous addition of HMF to expressed BM is necessary for infants with growth velocities <15 g/kg/day. This may save costs to the hospital as the use of HMF allowed for better weight gain and earlier discharge.
- Full Text:
- Date Issued: 2018
- Authors: Wicomb, Ra-eesa
- Date: 2018
- Subjects: Premature infants -- South Africa -- Nelson Mandela Bay Municipality , Birth weight, Low -- South Africa -- Nelson Mandela Bay Municipality Birth weight -- South Africa -- Nelson Mandela Bay Municipality Infants -- Nutrition Children -- Nutrition -- Research
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/23327 , vital:30529
- Description: Rationale: Worldwide, hospitals with premature units have one generalised objective, i.e. to achieve postnatal growth and body composition similar to that of a normal foetus of similar gestational age. Optimal nutrition leads to optimal neurodevelopment and breastfeeding (BF) is known as the golden standard for infant nutrition. Human breast milk (BM) has significant value for preterm and term infants and is of special benefit to HIV infected mothers. Maternal supplementation is provided as part of the standard protocol in certain hospitals in the Eastern Cape province to those mothers who breastfeed their low birth weight (LBW) infants after delivery. human milk fortifier (HMF) is a nutritional supplement that is added to expressed breast milk for feeding preterm infants in order to meet their high energy and protein needs and therefore supporting the recommended growth velocity of 10g/kg/day-15g/kg/day. Some hospitals within South Africa provide HMF to preterm infants as part of their standard nutritional protocol in order for the infant to gain weight if BM only failed to produce adequate results. To date, little to no South African studies support or discourage the use of HMF for LBW infants. This study aimed to describe the effect of maternal supplementation compared with breast milk with HMF, or a combination of maternal supplementation and breast milk with HMF, on growth velocity in hospitalised LBW premature infants within the Nelson Mandela Bay health district. The proposed study design followed a longitudinal, observational, descriptive study in a cohort of LBW infants. The study was analytical using quantitative empirical data. Study participants were selected, by using convenience sampling, at Dora Nginza Hospital, Zwide between October 2015 and August 2016 (ethics approval: EC_2016RP27_564). Quantitative data on anthropometric measurements was collected from study participants. Primary care givers provided written informed consent. Registered nurses were trained and performed anthropometrical measurements according to standardised methods. A structured questionnaire was completed by the principal reasarcher as a source of data collection. Numerical data was described using means and standard deviations. Chi squares were used to describe the associations between maternal risk factors and birth weight outcomes. ANOVA was used to determine the relationship between growth velocity and the various supplementation groups. A sample size of 91 LBW preterm infants and mother pairs were entered into this study. The majority of mothers, 64% (n=58) fell in the age category of 20-35 years old. Of the total maternal sample (n=88), 35% (n=31) were classified in the at risk age category, i.e. <20years old and >36years old. Out of the total infant sample (n=91), 65% (n=59) was classified as VLBW, 22% was LBW and 22% (n=20) was ELBW. No statistically significant association was found between infant growth velocity and maternal risk factors. The group receiving BM with HMF had a mean growth velocity of 19.75 g/kg/day (SD=6.45) that was statistically significantly (p<0.05) more than the other groups. The maternal supplementation only group and the maternal supplementation and BM fortification group showed mean growth velocities of 12.26 g/kg/day (SD=5.41) and 12.29 g/kg/day (SD=6.97) respectively. A post hoc test was done between growth velocity in the supplementated groups and the length of hospital stay. These results reveal that the group receiving BM with HMF had a significantly (p<0.05) shorter mean length of hospital stay of 11.29 days (SD=7.02), compared with the group on the combination of maternal supplementation and BM with HMF. In this study, infants receiving HMF with BM showed the highest growth velocity with the shortest hospital stay before discharge. In this group, infants were already receiving an adequate BM intake of 150-180 ml/kg/day prior to participation in the study. This meant that the HMF group consisted of more stable preterm infants compared to the rest of the supplementated groups. However, a large proportion of participants in the maternal supplementation group also showed adequate to good growth velocity. The researcher recommends the implementation of maternal supplementation only, as standard of care for all hospitalised lactating women. Furthermore, timeous addition of HMF to expressed BM is necessary for infants with growth velocities <15 g/kg/day. This may save costs to the hospital as the use of HMF allowed for better weight gain and earlier discharge.
- Full Text:
- Date Issued: 2018
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