Sankaranarayanan 2005.
Study characteristics | ||
Methods |
Study design: open randomised, controlled trial Recruitment date: 1 August 2003 to 31 January 2004 Treatment arms: 3 Follow‐up: 31 days, daily during hospital stay, weekly thereafter |
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Participants |
Randomised: a total of 224 babies (112 preterm and 112 term babies) were enrolled. In each gestation stratum, coconut oil n = 38, mineral oil n = 37, placebo n = 37 Inclusion criteria: full‐term neonates weighing 2500 grams or more were included if they fulfilled the following inclusion criteria:
Exclusion criteria:
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Interventions | Sessions began an hour after a feed. The total duration of each session was 5 minutes, and sessions were done 4 times a day. Term infants were massaged in a draught‐free room. Massage was given in prone and supine positions to include head, neck, trunk, and extremities. At completion of the massage, kinaesthetic stimulation was provided in the supine position by passive flexion and extension movements of the limbs at each large joint (shoulder, elbow, hip, knee, and ankle) as 5 events of 2 seconds. Massage was given by a trained person from day 2 of life until discharge, and thereafter by the mother until 31 days of age, 4 times a day. Babies were followed up daily until discharge and every week after discharge for anthropometry Intervention: coconut oil or mineral oil massage Comparator: massage using baby powder; methods of application and monitoring the same as in the oil groups Moisturiser/Emollient: coconut oil, mineral oil, and baby powder. No details of ingredients reported |
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Outcomes |
Primary outcome: weight gain velocity over first 31 days of life Secondary outcomes: length gain velocity, head growth, neurobehavioural outcome, incidence of adverse events Adverse events: in the preterm group, adverse events occurred in 6 babies, 2 each in the coconut oil, mineral oil, and placebo groups. All adverse events were mild rash and did not require discontinuation of application. Among term babies, 3 in the coconut oil group, 3 in the mineral oil group, and 2 in the placebo group developed mild rash that did not require discontinuation of application |
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Identification |
Country: India Setting: premature unit and postnatal wards of a major tertiary care centre in a metropolitan city in Mumbai Sponsorship source: Marico Industries Ltd. provided oils and placebo for the study |
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Declarations of interest | Marico Industries Ltd. is involved in the production of coconut oil. BM, AM, and RS Mohile are employees of Marico Industries. None of the authors from Sion Hospital have any shares in the company | |
Notes |