METHODSTrial settingThe Tu Du Hospital was a major birthing unit in Ho ChiMinh City, Vietnam, with approximately 60 000 deliveriesper year and 1200 obstetric beds. The neonatal unit had 180beds and admitted 16 200 neonatal cases in 2012, the yearof the study. The proportion of LBW babies was 12.5% inthis hospital. Intensive care facilities were under severepressure and incubators routinely held three small babiesat a time. The hospital’s protocol required that all babiesunder 2.5 kg or <37-week gestation be transferred to theNeonatal Unit for observation of the adaptation process,with resulting separation from the mother.Study design and participantsThis was a RCT, using sealed opaque envelopes. All infantsweighing between 1500 and 2490 g were screened foreligibility. The infants allocated to standard hospital caremade up the control group. The infants allocated to skin-toskincontact as a place of care rather than an incubator orcot made up the intervention group. Mothers testingpositive for human immunodeficiency virus and hepatitisB were excluded, as the hospital’s policy was that thesemothers should not breastfeed. Other exclusion criteriawere severe malformation, chromosomal abnormality, lifethreateningdisorders requiring complex technology, severeasphyxia at birth (Apgar score <4 at five minutes necessitatingprolonged resuscitation), neonatal convulsions, multiplebirths or mother in poor health.The obstetric nurses on duty informed the research teamwhenever a mother would potentially be giving birth to ababy in the weight range of 1500–2490 g (predicted byultrasound and an obstetrician). The study was conductedby two experienced neonatologists who provided standardisedclinical care to both groups and collected all the data.One of the neonatologists would inform the mother (andfather if required) and invite consent. After birth, if themother and infant satisfied the eligibility requirements afterweighing and assessment, an envelope with the groupallocation was drawn. If the baby was allocated to skin-toskincontact, the mother was asked to confirm her priorconsent. If the baby was allocated to the control group,consent for use of information was confirmed. Adherenceto the allocation was stringent and once treatment wasstarted, there were no deviations from the approvedprotocol. Due to the nature of the intervention, blindingwas not possible.Control groupIf the baby was allocated to the control group, the motherwas informed and the infant was separated from her inaccordance with the hospital’s protocol. After birth, thebaby was taken to the resuscitaire for suctioning and dryingwith a sterile cloth, stimulation of breathing, evaluation ofcondition and general examination. If deemed to be stable,the baby was measured and weighed, dressed in diaper,clothes, cap, gloves and socks. A vitamin K1 injection andeye prophylaxis were given. The infant was then coveredwith a blanket and transferred to the neonatal departmentabout 30 minutes after birth. Incubators set at 33°C or cotswere used, depending on the need for care. Mothers wouldnot see their infants until they were discharged from theneonatal department. Feeding was by bottle with artificialmilk for prematures (Similac Neosure) or by feeding tube 5–7 mL/kg per two hours at 30 minutes, three hours and atfive hours after birth, at which times all the vital sign datawere collected
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