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Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects
Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG
JAMA 1994 Sep 21;272(11):853-858
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; 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 investigate the effectiveness of individualized developmental care in reducing medical and neurodevelopmental sequelae for very low-birth-weight infants. DESIGN: Randomized controlled trial. SETTING: Newborn intensive care unit. PATIENTS: Thirty-eight singleton preterm infants, free of known congenital abnormalities, weighing less than 1,250 g, born before 30 weeks' gestation, mechanically ventilated within 3 hours of delivery and for more than 24 hours in the first 48 hours, randomly assigned to a control or an experimental group. INTERVENTION: Caregiving by nurses specifically trained in individualized developmental care; observation and documentation of the infants' behavior within 12 hours of admission, and subsequently every 10th day; developmental care recommendations and ongoing clinical support for the nurses and parents based on regular observation of the infant by developmental specialists; and the availability of special caregiving accessories. MAIN OUTCOME MEASURES: Medical outcome, including average daily weight gain; number of days the infant required mechanical ventilation, oxygen, gavage tube feeding, and hospitalization; severity of retinopathy of prematurity, bronchopulmonary dysplasia, pneumothorax, and intraventricular hemorrhage; pediatric complications; age at discharge; and hospital charges. Neurodevelopmental outcome, including Assessment of Preterm Infants' Behavior scale and quantified electroencephalography (2 weeks after due date); and Bayley Scales of Infant Development and Kangaroo Box Paradigm (9 months after due date). RESULTS: The infants in the experimental group had a significantly shorter duration of mechanical ventilation and supplemental oxygen support; earlier oral feeding; reduced incidence of intraventricular hemorrhage, pneumothorax, and severe bronchopulmonary dysplasia; improved daily weight gain; shorter hospital stays; younger ages at hospital discharge; and reduced hospital charges compared with the infants in the control group. At 2 weeks after their due dates, these infants also showed improved autonomic regulation, motor system functioning, self-regulatory abilities, and visual evoked potential measures; and at 9 months, they had improved Bayley Mental and Psychomotor Developmental Index scores, as well as Kangaroo Box Paradigm scores. CONCLUSION: Very low-birth-weight preterm infants may benefit from individualized developmental care in the neonatal intensive care unit in terms of medical and neurodevelopmental outcome.

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