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.

Results:45 infants were enrolled at a median age of 13 days(range 2 to 72 days). 79 and 76% of the TH and SSC were classified as high participation. No statistical differences were observed in GA (TH 27.6±2 weeks; SSC 26.5±2 weeks), birthweight (TH 997±216 grams; SSC 885±234 grams), postconceptional age at randomization (TH 29±1.9 weeks; SSC 28.9±1.9 weeks) or weight at randomization (TH 1031±225 grams; SSC 1020±240 grams).

No significant differences were observed in total daily caloric intake, the rate of weight gain or the incidence of culture positive sepsis (see table). No deaths occurred in either group.

Table 1 No caption available.
Full size table

Conclusion:There are no significant differences in the measured outcome variables between the two modalities of extended holding. Our analysis reassures us that both extended TH and SSC are safe modalities of parental care. We will continue our study to determine if a difference exists in infant development or parental psychosocial outcome.