Co-bedding twins: how pilot study findings guided improvements in planning a larger multicenter trial.

BACKGROUND: 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. OBJECTIVE: 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. RESULTS: 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. DISCUSSION: 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.

Current status of neonatal follow-up in Canada.

Follow-up programs in Canada collect audit and outcome research data, and provide clinical and preventive health care to extremely premature survivors and other new survivors of neonatal intensive care. Results of a 2001 to 2002 survey of Canadian follow-up programs showed a tremendous variation in the patient populations seen, the timing of visits and the evaluations performed. A description of the new Quebec consortium of follow-up programs is provided and possible future directions are discussed.

A population-based study to determine the performance of the Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale to Predict the Mental Developmental Index at 18 Months on the Bayley Scales of Infant Development-II in very preterm infants.

OBJECTIVES: To determine optimal ages to perform the Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) and optimal "cutoff" score of the CAT/CLAMS to screen very preterm infants (<31 weeks) for severe cognitive-adaptive delay and to ascertain the sensitivity, specificity and likelihood ratios using optimal cutoff scores compared with the Mental Developmental Index (MDI) of the Bayley Scales of Infant Development II. METHODS: A population-based cohort of very preterm infants who were born to mothers who resided in Nova Scotia or Prince Edward Island were evaluated at 4, 8, 12, and 18 months' corrected gestational age, which included a CAT/CLAMS by a physician. At 18 months' corrected gestational age, each child was assessed using the Bayley Scales of Infant Development II, the "gold standard" for developmental delay in young infants. The results of each CAT/CLAMS was compared with the 18-month MDI to identify significant developmental delay (MDI <70). RESULTS: Optimal scores on the CAT/CLAMS to identify correctly MDI <70 were determined by using the kappa statistic for chance independent agreement. Sensitivities and specificities for optimal cutoff scores were as follows: 4-month score <109 (88% and 37%), 8-month score <98 (75% and 82%), 12-month score <81 (63% and 99%), and 18-month score <83 (88% and 98%). CONCLUSION: Sensitivity and specificity of the CAT/CLAMS are high in very preterm infants at identifying major developmental delay at 12 and 18 months. For follow-up programs without psychology services, the CAT/CLAMS at 12 and 18 months is a reasonable screening tool to determine which children need expedited psychology referral for cognitive delay.

Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age.

OBJECTIVE: To determine the efficacy of sucrose analgesia for procedural pain during the first week of life in preterm neonates in neonatal intensive care units on enhancing later clinical outcomes. METHODS: A total of 107 preterm neonates who were born at <31 weeks' postconceptional age (PCA) entered this double-blind, randomized, controlled trial within 48 hours of birth at 3 level III university-affiliated neonatal intensive care units in Canada, and 103 completed the study. Sucrose (0.1 mL of 24%) or sterile water was administered orally up to 3 times, 2 minutes apart, for every invasive procedure during a 7-day period. Motor development and vigor, and alertness and orientation components of the Neurobehavioral Assessment of the Preterm Infant were measured at 32, 36, and 40 weeks' PCA; Score for Neonatal Acute Physiology was measured on the last day of intervention; and Neuro-Biological Risk Score (NBRS) was measured at 2 weeks of age and at discharge. Primary analyses of covariance were applied for each outcome to compare group differences followed by secondary analyses using standard linear regression within each group to determine predictors of outcomes. RESULTS: Although there were no differences between the groups on any outcomes, there were significant dose-related effects within each group. In the sucrose group only, higher number of doses of sucrose predicted lower scores on motor development and vigor, and alertness and orientation at 36 weeks', lower motor development and vigor at 40 weeks', and higher NBRS at 2 weeks' postnatal age. Higher number of invasive procedures was predictive of higher NBRS both times in the water group. CONCLUSIONS: Repeated use of sucrose analgesia in infants <31 weeks' PCA may put infants at risk for poorer neurobehavioral development and physiologic outcomes. Additional study is needed to determine the most appropriate age and duration of sucrose analgesia in preterm infants.