NCT00552383

The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

The Impact of Developmental Care in the Neonatal Intensive Care Unit: The Edmonton Randomised Controlled Trial of NIDCAP (Newborn Individualised Developmental Care and Assessment Program)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 2 Days – 1 Week
• Healthy volunteers: Not accepted

Summary

NIDCAP based developmental care is a method of looking after preterm infants that is guided by the infant's behavioural cues, and that actively involves parents in the care of their infant. There is limited evidence that outcomes for infants are improved if they receive NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its effects on developmental outcomes at age 18 months.

Detailed description

This RCT differs from previous trials in that it is conducted in the post - surfactant era \[an intervention that has greatly changed clinical neonatology\]. The number of infants required to demonstrate a clinically relevant outcome \[Length of Hospital Stay\] has been calculated a priori. The infants will be tracked for outcome data after transfer to peripheral nurseries \[a reality in today's healthcare environment\], allowing generalisability of results to other high risk, referral Neonatal Intensive Care units. Neurodevelopmental outcomes will be evaluated at 18 months; \[these data are sparse from previous studies\]. This RCT will therefore demonstrate whether NIDCAP based care is truly an effective intervention for the very low birth weight infant.

Conditions

• Infant, Premature

Interventions

Type	Name	Description
PROCEDURE	NIDCAP based developmental care	Infants in the intervention arm will receive care in the NICU by nursing staff who have received basic education in NIDCAP - based developmental care. They will also have NIDCAP behavioural observations performed by NIDCAP - Certified staff \[this includes 3 of the investigators\], at intervals during their stay at the study site NICU. These behavioural observations form the basis for behaviourally guided "baby -friendly" care, so that the timing and pace of caregiving is synchronised to the infant's readiness. Parents are actively encouraged to become the infant's primary caregiver in the NICU.

Timeline

• Start date: 1998-09-01
• Completion: 2004-12-01
• First posted: 2007-11-01
• Last updated: 2007-11-01

Locations

1 site across 1 country: Canada