Co-bedding twins: how pilot study findings guided improvements in planning a larger multicenter trial. Randomized controlled trial evaluating the effects of cobedding on weight gain and physiologic regulation in preterm twins in the NICU. Co-bedding versus single-bedding premature multiple-gestation infants in incubators. Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial.
Co-bedding, a developmental care practice for twins and multiples, has been theorized as a strategy to decrease the adverse neurodevelopmental effects that may be associated with hospitalization.
                The aim of this study was to determine the feasibility of study design, methods, and the measurement of desired outcomes for the development of a larger multicentered study.
                Study findings were used to estimate effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up. Results were incorporated in the development of a larger multicentered trial grant proposal.
                Pilot studies can play an important role in the development of a competitive grant proposal and efficient conduct of a research trial. Pilot studies strengthen a proposal by providing essential baseline information. A general overview of the purpose of pilot studies is provided here, along with a description of the process of using findings from a pilot study to inform the development of a larger multisite trial. Findings from this pilot study examining the effects of co-bedding on twins and their parents are used to revise the research protocol for a larger multisite trial. These changes, which lead to improvement to the protocol, and the rational for these changes are highlighted. To compare the differences in growth and physiologic regulation in cobedded preterm twins versus individually bedded preterm twins while in the neonatal intensive care unit (NICU).
                Infants born between 28 to 34 weeks gestation in a Level III NICU were eligible for enrollment into the study. Forty-nine sets of twins were enrolled in the study and 41 sets were ultimately analyzed. There were 21 twin sets (42 infants) in the experimental group and 20 sets (40 infants) in the control group.
                A prospective randomized design was used.
                Parents of twins in a level III NICU were approached for consent to participate in the study. Twins were randomized using sealed envelopes that designated placement in either the control or experimental group. Twin sets who were randomized to the control group received routine care in separate beds. Twin sets in the experimental group received routine care in the same bed. Guidelines for positioning of cobedded twins were utilized. Treatment and data collection started when infants met the inclusion criteria for the study.
                Measurements of weekly weight gain and episodes of apnea/bradycardia/desaturation (A/B/D) were collected for each group.
                After adjusting for baseline weight in an analysis of covariance model, the cobedded group demonstrated a significantly higher mean weight compared to the control group at week 1 (1,644 vs. 1,572 grams, respectively, F = 11.6, P = 0.001) and at week 2 (1,755 vs. 1,693 grams, respectively, F = 5.7, P = 0.02). There was no difference in the median number of total combined A/B/D episodes between the 2 groups.
                A greater increase in mean weight gain was noted in the cobedded group compared to the control group. To compare the physiological stability and behavioral effects of co-bedding with those of single-bedding premature multiple-gestation infants in incubators as well as the psychological effects on their parents.
                Prospective, randomized, repeated measure.
                Convenience sample of 16 infants and 8 parents in the co-bedded group, and 21 infants and 11 parents in the control group.
                Infants in the study group were co-bedded in incubators.
                Baseline and posttesting for parental state anxiety, maternal attachment, and parental satisfaction measures; infant sleep-wake synchronicity; physiological measures; and stress cue measures during baseline and activity.
                Repeated measures 5 (time) x 2 (group) analysis of variance found significant differences in infant daily weight, feeding amount, and high-activity heart rate. There was no difference in parental state anxiety, maternal attachment, and parental satisfaction scores by group, except for higher baseline parental satisfaction scores in the co-bedded group.
                This research demonstrated the safety of co-bedding multiple-gestation infants in incubators but did not find any significant clinical improvement in infant or parental outcomes with co-bedding. Neonatal intensive-care unit providers should educate staff and parents about the potential benefits of co-bedding and consider developing policies and procedures for co-bedding in both incubators and cribs. Co-bedding of multiple-gestation infants may be provided as an adjunctive developmental care strategy if parents desire this intervention. Cobedding of preterm twin infants provides tactile, olfactory, and auditory stimulation and may affect pain reactivity. We carried out a randomized trial to assess the effect of cobedding on pain reactivity and recovery in preterm twin neonates.
                Stable preterm twins (n = 67 sets) between 28 and 36 weeks of gestational age were randomly assigned to a cobedding group (cared for in the same incubator or crib) or a standard care group (cared for in separate incubators or cribs). Pain response (determined by the Premature Infant Pain Profile [PIPP]) and time to return to physiologic baseline parameters were compared between groups with adjustment for the nonindependence of twin infants.
                Maternal and infant characteristics were not significantly different between twin infants in the cobedding and standard care groups except for 5-minute Apgar <7 and postnatal age and corrected gestational age on the day of the heel lance. Mean PIPP scores were not different between groups at 30, 60, or 120 seconds. At 90 seconds, mean PIPP scores were higher in the cobedding group (6.0 vs 5.0, P = .04). Recovery time was shorter in the cobedding group compared with the standard care group, (mean = 75.6 seconds versus 142.1 seconds, P = .001). No significant adverse events were associated with cobedding. Adjustment for nonindependence between twins and differences in baseline characteristics did not change the results.
                Cobedding enhanced the physiologic recovery of preterm twins undergoing heel lance, but did not lead to lower pain scores.
There was insufficient evidence on the benefits and harms of co-bedding stable preterm twins to make any recommendation in practice. There is a need for future studies that are adequately powered to detect clinically important differences in growth and neurodevelopment. Such studies should also assess harms including infections and medication errors, and caregiver satisfaction.