Effect of a standardized feeding regimen on early neonatal growth in low and very low birth weight neonates at Kenyatta National Hospital
Background: Introduction of standardized feeding regimens for neonates has been associated with better weight gain, earlier attainment of full enteral feeds and reduced risk of necrotizing enterocolitis (NEC) in high income countries. Better weight gain is in turn associated with better short and long-term physical and neurological outcomes for low birth weight neonates. This pilot study was aiming to assess the effect of a standardized feeding regimen on early neonatal growth. Objectives: The primary objective was to determine the effect of a standardized feeding regimen (SFR) on neonatal growth, measured at twenty eight days of age, and obtain preliminary data on safety and feasibility. The specific objectives were to describe and compare the average daily weight gain between the two feeding groups, that is, the standardized feeding regime (SFR) group and the current feeding regime (CFR) group at 28 days of age; to describe and compare the proportion of neonates in the two feeding groups who had attained or surpassed their birth weight by 21 days of age and to describe the proportion of neonates that attained full enteral feeds at or before 7 days of age. Design: Open randomized control trial. Methods: Seventy two neonates with birth weights between 1000g and 1999g were randomly assigned into two feeding arms, one(CFR) with 37 and the SFR group with 35 babies. Initial measures taken included birth weights taken using a digital weighing scale able to measure up to 10 grams. Those in the intervention arm received enteral feeds according to a standardized feeding regimen beginning within 4 hours of age for the 1500g -1999g subgroup and at 24 hours for the 1000g -1499g neonates. The SFR consisted of early introduction of feeds and rapid increment in volume of feeds .The control group's feeding was the current feeding regime (CFR) in the newborn unit in Kenyatta National Hospital which mainly consisted of slow introduction of, and low volume increment of enteral feeds. Main outcome measure: Average daily weight gain calculated at 28 days of age. Secondary outcomes were; time (in days) till regaining of birth weight, time to attaining full enteral feeds and frequency of feed intolerance or NEe. Data Analysis: Analysis was by intention to treat. Descriptive statistical and analytical methods were used for data evaluation and results presentation. Results: Seventy two neonates were recruited and randomly assigned to the two feeding groups with thirty seven in the CFR group and thirty five in the SFR group. Thirteen patients (18.05%) died, six (8.33%) developed feed intolerance and one was lost to follow-up. The baseline characteristics, including the number of males and females, numbers in the weight subgroups and mean birth weight, between the two groups were the same. The neonates on the SFR had a mean weight gain of 14.1 g/kg/ day compared to a mean weight gain of 9.8 g/kg/ day in the CFR group and this was a statistically significant difference (p= <O.OO1).Thoseon the SFR also attained full feeds earlier at a mean of 5.6 days compared to a mean of 7.0 days in the CFR group and this was a statistically significant difference (p=0.002). Those babies fed by the SFR regained their birth weight by a mean of 7.2 days compared to a mean of 9.9 days in the CFR group and this too was statistically significantly different(p=O .001). The episodes of significant feed intolerance did not differ between the two feeding regimes. There was no difference in mortality between the two feeding regimes though the study was not powered to detect a difference between the two groups. Conclusions: There was a statistically significant weight gain advantage and earlier attainment of full feeds and regaining of birth weight in the neonates fed using the standardized feeding regime. The study did not find any difference in the episodes of feed intolerance between the two feeding regimes. Mortality between the two groups did not differ though the study was not powered to detect a difference.