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A randomized, controlled trial to evaluate the effects of the newborn individualized developmental care and assessment program in a Swedish setting |
Westrup B, Kleberg A, von Eichwald K, Stjernqvist K, Lagercrantz H |
Pediatrics 2000 Jan;105(1 Pt 1):66-72 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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* |
BACKGROUND AND OBJECTIVE: Family-centered developmentally supportive care of very low birth weight infants, provided by the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been reported to have positive medical and economic impacts. Our aim was to investigate its effect on need of ventilatory assistance, growth, and hospitalization in a Swedish setting. METHODS: Preterm infants born between September 1994 and April 1997 with a gestational age < 32 weeks and with a need of ventilatory assistance at 24 hours were randomly assigned to either NIDCAP (n = 12) or conventional care (n = 13). The 2 groups were comparable (median (range)) with respect to birth weight (1,083 (630 to 1,411) versus 840 (636 to 1,939) g), head circumference (24.0 (22.3 to 26.5) versus 24.0 (21.1 to 30.0) cm), gestational age (27.6 (24.0 to 28.7) versus 26.1 (23.9 to 30.3) weeks), female/male ratio (3/9 versus 9/8) and Clinical Risk Index for Babies (4.0 (0 to 11) versus 6.0 (2 to 15)). The infants in the intervention group were cared for in a separate room by a group of specially trained nurses. Formal weekly observations of these infants starting within 3 days after birth and continuing until 36 weeks postconception were used to develop individualized care plans. These plans provided recommendations as to how care might be attuned to the current developmental stage of the infant and how the family might be supported and stimulated to participate in this care. The treatment of the 2 groups was in all other respects identical. RESULTS: The duration of mechanical ventilation (median (range) was 2.8 (0 to 36.7) days in the intervention group versus 4.8 (0.1 to 29.8) days; not significant (NS)) among the controls and continuous positive airway pressure was applied for 26.1 (6.9 to 52.0) versus 43.9 (5.0 to 65.1) days. Supplementary oxygen was withdrawn at 33.0 (29.3 to 35.7) versus 38.1 (33.1 to 44.9) weeks of postconceptional age (PCA). The weight gain up to 35 weeks of PCA was 13.0 (6.7 to 21.0) versus 9.8 (6.8 to 16.6) g/day (NS). The head growth up to 35 weeks of PCA was 0.73 (0.56 to 1.3) versus 63 (0.56 to 0.77) cm/week (NS). The age of the infant at discharge was 38.3 (36.1 to 57.7) versus 41.0 (36.9 to 48.4) weeks of PCA (NS). CONCLUSIONS: NIDCAP does not seem to have detrimental effects on Swedish very low birth weight infants in comparison with conventional care. Indeed, NIDCAP might even be advantageous.
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