| Background. Maternal skin contact during a tissue breaking procedure lowers pain reactivity and enhances physiological recovery. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. No studies have examined whether the contact or presence of a twin would have a similar comforting effect.;Purpose. To compare the comfort effect of co-bedding by contrasting preterm twins who are co-bedding and those who are not on pain response during a tissue breaking procedure (heel lance).;Methods. Following consent, 67 eligible twin sets, admitted to the Neonatal Intensive Care Unit (NICU) were stratified in pairs by gestational age (≤ 31 6/7 weeks or ≥ 32 weeks) and site and then randomly assigned to a co-bedding group, n=36, (cared for in the same incubator or crib) or a standard care group, n=31, (cared for in a separate incubator or crib). Pain response was determined by physiologic and videotaped facial reaction in accordance with the Premature Infant Pain Profile (PIPP). Additional outcomes included physiologic time to recovery, alterations in salivary cortisol, heart rate variability, frequency of additional 24% sucrose doses required, and response of the co-twin. Sample size was calculated using a 2-sided alpha error of 0.05 and a power of 80 percent. Sixty four sets of twins or a total of 128 infants were needed to detect a difference of 1 point or greater change (SD 2.0) in the PIPP scores if such a difference is in fact caused by co-bedding. Analysis was based on the intention-to-treat principle and compared the means in the two groups before and after treatment and contrasted the mean difference between groups using 95 percent confidence intervals and a 2 sided P value of 0.05.;Results. Mean PIPP scores were highest at 30 seconds post lance and not significantly different between the groups, 7.1 (SD 2.8) in the co-bedding group and 7.2 (SD 3.4) in the standard care group, P=0.91. Nor were they significantly different at 60 or 120 seconds. At 90 seconds, mean scores were higher in the co-bedding group, 6.0 (SD 3.0) vs. 5.0 (SD 1.8), P=0.04, [95% CI -1.99 to -0.02] in the standard care group. Recovery time post lance was over a minute shorter, M=75.6 seconds (SD 70.0), in the co-bedding condition compared to standard care, M=142.1 seconds (SD 138.1), P=0.001, mean difference of 64.5 seconds (95% CI. 25.6-103.3). No group differences were noted in baseline cortisol levels (0.36 ug/dl if assigned to receive co-bedding and 0.43 ug/dl in the standard group) while cortisol levels 20 minutes post lance were significantly lower in the co-bedding group, 0.28 ug/dl (SD 0.25) versus 0.50 ug/dl (SD 0.73). Similarly, mean change in cortisol from baseline was lower in the co-bedding group, -0.06 ug/dl compared to the standard care group, 0.14 ug/dl, P=0.05. Co-bedding infants were significantly less likely to receive any form of additional non-pharmacologic strategy (non-nutritive sucking, swaddling or facilitated tucking), 58.2% versus 95%, P<0.001. Heart variability, frequency of additional sucrose dosages, co-twin response and incidence of adverse events were not significantly different between the groups.;Conclusions. The results of this randomized controlled trial provide evidence that co-bedding enhances physiologic recovery and diminishes the stress response of preterm twins undergoing heel lance in the NICU but did not lead to lower pain scores. Co-bedding did not decrease the frequency of additional 24% sucrose doses. Nor did co-bedding contribute to higher adverse effects for the twin undergoing heel lance or his/her co-twin.Clinical Trial Registry - NCT00917631. |
