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. Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions. A three-center, randomized, controlled trial of individualized developmental care for very low birth weight preterm infants: medical, neurodevelopmental, parenting, and caregiving effects. Randomized clinical trial of an oscillating air mattress in preterm infants: effect on apnea, growth, and development. The effect of bedrest in hospital on fetal outcome in pregnancies complicated by intra-uterine growth retardation. Is routine hospitalization needed in antenatal care of twin pregnancy?
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. Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
                Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
                Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
                The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions. Medical, neurodevelopmental, and parenting effects of individualized developmental care were investigated in a three-center, randomized, controlled trial. A total of 92 preterm infants, weighing less than 1250 g and aged less than 28 weeks, participated. Outcome measures included medical, neurodevelopmental and family function. Quality of care was also assessed. Multivariate analysis of variance investigated group, site, and interaction effects; correlation analysis identified individual variable contributions to significant effects. The results consistently favored the experimental groups. The following contributed to the group effects: shorter duration of parenteral feeding, transition to full oral feeding, intensive care, and hospitalization; lower incidence of necrotizing enterocolitis; reduced discharge ages and hospital charges; improved weight, length, and head circumferences; enhanced autonomic, motor, state, attention, and self-regulatory functioning; reduced need for facilitation; and lowered family stress and enhanced appreciation of the infant. Quality of care was measurably improved. Very low birth weight infants and their parents, across diverse settings, may benefit from individualized developmental care. To investigate claims that oscillating mattresses reduce apnea of prematurity and improve growth and neurobehavioural development, we performed a randomized clinical trial using a predetermined sample size. Preterm infants weighing from 750 to 1750 gm at birth were randomly assigned, by 250 gm strata, to either a conventional mattress (n = 63) or to an air mattress (n = 59) oscillating at 14 to 16 regular pulses per minute. Infants remained on the oscillating air mattress for at least 7 days or until 34 weeks postmenstrual age. Apneic episodes occurred and required treatment equally in the two groups; this lack of an effect was seen for both sexes and all weight groups. Both weight and energy intake were similar. Neurobehavioral development as shown by sleep state, habituation testing, and behavioral assessment at term, 3, 6, and 12 months was similar in the two groups. There was no difference in the incidence of neurologic abnormalities. We conclude that an oscillating air mattress has no prophylactic value in reducing apnea and does not enhance growth and development. A prospective study was made to evaluate whether bedrest in hospital is beneficial in pregnancies where intra-uterine growth retardation (IUGR) was suspected. Diagnosis was based on routine fetometry at 32 weeks of gestation, in conjunction with general ultrasound screening. 107 patients with suspected IUGR-pregnancies were divided into two groups, 49 in a hospital bedrest group and 58 in an 'out-patient' group. Fifteen women in the bedrest group refused hospitalization, and 8 women in the out-patient group had to be hospitalized for medical reasons other than suspected growth retardation, leaving 79% of the women in their allocated group. The women in the bedrest group were hospitalized for a mean duration of 29.2 days (range 5-54). The results suggest that bedrest in hospital is not beneficial, either to fetal growth or to pregnancy outcome. A prospective study was carried out to evaluate the significance and efficacy of routine hospital bed rest in prevention of premature birth and pregnancy complications compared to specialized antenatal care at the outpatient clinic of 73 twin pregnancies. The twin pregnancies were screened in health centers by means of symphysis-fundus measurement, and the diagnosis was confirmed by ultrasound examination at the outpatient clinic. On the average the ultrasonic diagnosis was performed during the 23rd gestational week; at this visit the women were divided into two groups with similar follow-up to the end of the 29th gestational week. At this stage one of the groups was hospitalized unless there had been indications for earlier admission. In the hospital group, the mean for gestational week at delivery was 36.7 (+/- 2.4) and in the outpatient group 37.4 (+/- 1.8) respectively (N.S.). There was no difference in the rate of pregnancy complications between the groups too. No statistical differences in the perinatal mortality (7.1% and 1.1% respectively) or birthweights of the newborns were found, either. Present results do not support the idea of using routine hospital bed rest. It could not be proved to have positive effects on the gestational age, birth weight and perinatal mortality of the newborns, nor to the pregnancy complications. In our opinion early diagnosis of twin pregnancy is of decisive importance and specialized ambulatory follow-up could be employed instead of routine bed rest in antenatal care of twin pregnancy.
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.