No change in developmental outcome with incubator covers and nesting for very preterm infants in a randomised controlled trial
- C M Maguire1,
- F J Walther1,
- P H T van Zwieten2,
- S Le Cessie3,
- J M Wit1,
- S Veen1,
- On behalf of the Leiden Developmental Care Project
- 1Department of Pediatrics, Subdivision of Neonatology, Leiden University Medical Center, Leiden, The Netherlands
- 2Department of Pediatrics, Subdivision of Neonatology, Haga Hospital, Juliana Children’s Hospital, The Hague, The Netherlands
- 3Department of Medical Statistics, Leiden University Medical Center, The Netherlands
- Dr S Veen, Department of Pediatrics, J-6-S, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands;
- Accepted 27 July 2008
- Published Online First 14 August 2008
Objective: To investigate in a randomised controlled trial the effect of basic elements of developmental care (incubator covers and positioning aids) on growth and neurodevelopment in infants born at < 32 weeks.
Method: Infants were randomised within 48 h of birth to a developmental care (DC) or standard care (C) group. Outcome measures at 1 and 2 years corrected age were growth, standardised neurological examinations, and mental (MDI) and psychomotor (PDI) development (Dutch version of the Bayley Scales of Infant Development II).
Results: 192 infants were recruited (DC = 98; C = 94). Thirteen infants (DC = 7, C = 6) were excluded because they were admitted for <5 days or died within the first 5 days. In total, 179 infants met the inclusion criteria. In-hospital mortality was 12/91 (13.2%) in the DC group and 8/88 (9.1%) in the C group. Assessments were carried out on 147 children (DC = 74, C = 73) at 1 year and 142 children (DC = 72, C = 70) at 2 years. No significant difference in growth, neurological outcomes or MDI was found. A positive trend in PDI at 1 year (p = 0.05) did not continue once the children reached 2 years. There was no difference found when neurological and developmental scores were combined.
Conclusions: Basic developmental care has no positive effect on neurological and mental development or growth at 1 and 2 years of age in infants born at <32 weeks. A positive effect on psychomotor development at 1 year did not continue at 2 years of age.
Trial registration number: ISRCTN84995192.
Funding: This study was funded by the ZONMW (grant 2100.0072) and the Health Care Efficiency Research Fund LUMC.
Competing interests: None.
Ethics approval: Obtained.
Patient consent: Parental consent obtained.