This is a secondary analysis of the randomized controlled trial which was conducted in a tertiary care nursery of the Department of Neonatology, Fernandez hospital, Hyderabad from November 2013 to August 2015. The study protocol was approved by the Institutional research board (IRB) of Fernandez hospital, Hyderabad and the study is registered at clinical trial registry, India with registration number CTRI/2014/05/004625.
Written informed consent was obtained from the parents or guardian before randomization of the infant in either of groups. They were provided with written and verbal information including on the potential risk and benefits involved on the research. One copy of research fact sheet was kept with the parents. Parents were explained about the voluntary nature of participation in the research, about non-penalization in event of non-participation and about the option of withdrawing their infant from the study at any point they wished without offering any reason. Confidentiality of the subjects was maintained.
Infants with birth weight less than 1100 g, gestation age ≤ 32 weeks, singleton, tolerating spoon or tube feeds of 150 ml/kg/day, not on intravenous fluids, breathing room air and hemodynamically stable (without any vasopressor support, normal blood pressure and maintaining temperature in incubator care with <25 % heater output) were included in the study. Infants with major malformations were excluded.
All eligible preterm infants were randomized to receive either ‘Kangaroo ward care’ (KWC) or ‘Intermediate Intensive Care’ (IIC) group once the infant reached a weight of 1150 g. Random numbers were generated by a web based computer programme (research randomizer.org). Individual group assignments were placed in a serially numbered, opaque sealed envelope that was opened only after obtaining consent from the parents.
Intervention
‘Kangaroo Ward Care’ (KWC)
Infants randomized to KWC group were shifted to the Kangaroo ward immediately after randomization. In the Kangaroo ward, care of the baby including spoon feeding, diaper change, monitoring for complications was done by the mother supervised by a trained dhai (a female attendant trained specially in taking care of neonates and skilled in doing daily care activities of the neonates like spoon feeding, ensuring breast feeding in term infants, changing diapers, clothing, early detection of neonatal complications and advising mother on baby care). The infants were kept in skin-to-skin contact (KMC), firmly attached to the mother’s chest with a cloth binder during KMC sessions. Front open gowns were made available for the mothers and privacy was provided to them for their use. Comfortable chairs and beds were provided for the mothers for practicing KMC. The duration in which the infant was not in skin to skin contact, the infant was wrapped properly with clothes, cap, and socks and placed in a well cushioned baby swaddlers. Mothers were taught to identify hypothermia and cold stress.
‘Intermediate Intensive Care’ (IIC)
Infants randomized to IIC group were cared for in the intermediate care area of the NICU. Infants were cared under incubator/warmer in servo control mode for thermoregulation. Mothers were encouraged to visit the baby as many times as possible and were encouraged for skin to skin contact in the intermediate care unit for as long as possible. When the infants were not in skin to skin contact with the mother, it was in the incubator/warmer. All the baby care activities were done by the neonatal nurses. When the infant reached 1250 g, it was shifted to the kangaroo ward and subsequently, the baby care was similar to that in the KWC group.
In both the groups, mothers were trained to do KMC for as many hours per day as possible ensuring a minimum of six hours per day. If infant was on tube feeds, feeding was done by a trained nurse or dhai. Infants were discharged home at a minimum weight of 1400 g and gaining weight of ≥ 10gm/day on 3 consecutive days. Mothers were encouraged to continue skin to skin contact at home as long as the baby was tolerating it.
Feeding in both the groups was expressed breast milk (EBM) given with a paladi (a traditional spoon used for feeding neonates in India) at 2 hourly intervals. EBM was supplemented with human milk fortifier (HMF) for as long as the infant was on gavage or paladi feeds. When on direct breastfeeds, human milk fortifier was replaced with calcium, phosphorus, multivitamins and iron supplements. When expressed breast milk was not available a preterm formula was used. Supplements were used as per the unit protocol.
The data was collected in a predesigned proforma. The data included baseline variables like birth weight, weight at enrollment, discharge weight, gestation at birth, at enrollment and at discharge, sex, antenatal steroids (complete, partial, nil, multiple courses), mode of delivery (vaginal/cesarean), one minute and five minute Apgar, nutrition (partial /total parental nutrition), postnatal age at full feeds and also neonatal morbidities like blood culture positive sepsis, Necrotizing enterocolitis (NEC) and Stage [4], Patent ductus arteriosus (PDA) (medical or surgical management) [5], ROP and staging [6], IVH/PVL and grading [7, 8] and the cost variable after the randomization.
Cost analysis
Cost incurred by the patients in both the groups was from the time of randomization to hospital discharge. The hospital costs were determined by “top-down” accounting methods and included consultant charges, specialist charges, duty doctor charges, nurse’s charges, supporting staff charges, intervention charges, laboratory investigation charges and procedural charges if any. The out of pocket expenditure of parents was calculated from standard “bottom-up” cost-accounting methods and included the charges paid by the parents from the time of randomization till discharge.
Statistics
Comparisons between study groups for discrete variables was performed with the chi-square or Fisher’s exact test. Continuous variables were compared by means of Student’s t test or nonparametric tests, when appropriate. It was an intention to treat analysis and all patients were analyzed according to the group to which they were allocated, regardless of compliance with treatment or contamination of the intervention. The foreign exchange rate used in the analysis was 66 Indian rupees = 1 USD (2015).