Patients and methods
HC, blindness, hydrocephaly, congenital anomalies, breast milk, weight gain, sepsis, gastrointestinal anomaly
SEPSIS, BLINDNESS, HYDROCEPHALY, INTRAVENTRICULAR HEMORRHAGE GRADE II, PERIVENTRICULAR LEUKOMALACIA, BLIND, HEART FAILURE, FMS
This double blind randomized controlled (RCT) trial was conducted at Nemazi and Hafez hospitals affiliated to Shiraz University of Medical Science, Iran, from Feb 2017 to April 2018. All stable preterm infants with birth weight less than 1500 g and GA≤33 weeks who were admitted to these NICUs were assessed for eligibility and enrolled after fulfilling the inclusion criteria. Each preterm neonate who reached full enteral feeding (150–180 ml/kg/day) with either FBM or PF was included. The exclusion criteria of the study were refusal by either parents or neonatologist, presence of severe congenital anomalies especially gastrointestinal anomaly, intraventricular hemorrhage grade III or more, hydrocephaly, periventricular leukomalacia, large PDA with signs of heart failure, sepsis, surgery, systemic steroids use, and persistent oral feeding intolerance during the study. Feeding intolerance was managed by temporary interruption of human milk fortifier or protein supplement or formula, but if intolerance was repeated more than 3 times, the infant was excluded from the study.The participants were divided into two groups. One group received protein supplements (intervention group), while the other group did not (control group). We used a randomized sampling method via blocked randomization. Both the parents and the data collector were unaware of the group allocation. The only individuals who were aware of the protein supplement allocations were a research fellow and a nurse who were not involved in the measurements.All participants received 3 g/kg/day parenteral protein as Aminovein infant 10% (FRESENIUS KABI Company, Germany) from the first hours of life and gradually increased to 3.5 g/kg per day. Enteral feeding started as early as possible. The preferable feeding method was breast milk. When the total volume of breast milk reached 120 ml/kg/day, human milk fortifier powder (Aptamil FMS, DANONE company, Netherlands) was added and increased daily to its complete dosage of 4 scopes per day (4.4 g) which contain 1.1 g protein. When the neonates received 150–180 ml/kg/day FBM, they were considered as full fed. By considering the amount of protein of breast milk as an average of 1.5 g/dl [All the neonates were evaluated for daily weight gain with a seca345 scale with 5-gram accuracy. They were also evaluated weekly regarding their head circumference (HC) and linear growth velocity by the special nurse, and the results were recorded as cm per week. Data were collected in predesigned forms with codes assigned to each patient to preserve the patients’ confidentiality and blindness of the study. We used the Fenton curve calculator online from the site peditools.com for calculating the exact percentile of anthropometric measurements. The special nurse was not aware of the case or control groups.