Extended Traditional Holding (TH) and Skin-to-Skin Care (SSC) for Newborn Infants ≤1500 grams. A Randomized Controlled Trial. Results of an Interim Analysis † 1115

Objectives: This open randomized trial compares the effects of two modalities of extended holding (TH and SSC) on growth and development of VLBW infants. The following results form part of an interim analysis which specifically looked at growth, morbidity and mortality.

Methods:Infants who met eligibility criteria (birthweight 600 to 1500 grams, medical stability, on minimal respiratory support [MAP ≤8, NCPAP and FiO₂ ≤ 40%]) were randomized to TH or SSC. Parents were permitted to hold infants for up to 4 hours twice a day with continuous monitoring until the baby reached 2000 grams or was discharged home(time/event*). During TH infants were wrapped in a blanket, and held in supine position. During SCC infants were clothed only in a diaper, and held in prone position (at a 45⁰ angle) in direct skin-to-skin contact with the parents bare chest. The amount of holding was monitored on a daily basis to define a high participation group (≥ then 3 interventions/7 days) and low participation group (<then 3 interventions/7 days). Daily weight and caloric intake were recorded.

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