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Early intervention in low-birth-weight premature infants: results through age 5 years from the Infant Health and Development Program
Brooks-Gunn J, McCarton CM, Casey PH, McCormick MC, Bauer CR, Bernbaum JC, Tyson J, Swanson M, Bennett FC, Scott DT, Tonascia J, Meinert CL
JAMA 1994 Oct 26;272(16):1257-1262
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the persistence of effects on health and development at age 5 years of the Infant Health and Development Program, an early childhood intervention that was provided to low-birth-weight (LBW) premature infants from neonatal discharge through age 3 years. DESIGN: Randomized, controlled, multicenter trial, stratified by two LBW groups: lighter (<= 2,000 g) and heavier (2,001 to 2,500 g). SETTING: Eight socioeconomically heterogeneous clinical sites. PARTICIPANTS: Of 985 eligible infants weighing 2,500 g or less and at 37 weeks' or less gestational age, 377 infants were randomly assigned to the intervention group and 608 to the follow-up only group. About two thirds of the infants in each group were in the lighter LBW stratum, and one third were in the heavier LBW stratum. INTERVENTION: The intervention group received home visits (from neonatal discharge through age 3 years) as well as center-based schooling (from 1 to 3 years of age). Children in both groups received pediatric surveillance. MAIN OUTCOME MEASURES: Cognitive development, behavioral competence, and health status. RESULTS: At age 5 years, the intervention group had full-scale IQ scores similar to children in the follow-up only group. However, in the heavier LBW stratum, children in the intervention group had higher full-scale IQ scores (3.7 points higher; p = 0.03) and higher verbal IQ scores (4.2 points higher; p = 0.02). No significant differences between intervention and follow-up only groups in cognitive measures at age 5 years were noted in the lighter LBW infants. The intervention and follow-up groups were similar in behavior and health measures regardless of LBW stratum. CONCLUSION: The early childhood intervention provided in the first 3 years of life had effects on heavier LBW premature infants' IQ and verbal performance at age 5 years that were not observed for lighter LBW premature infants. The intervention did not affect health or behavior at age 5 years in either LBW stratum.

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