The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

University of Alberta

Status: Completed

Conditions: Infant, Premature

Treatments: Procedure: NIDCAP based developmental care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00552383

199700189 (AHFMR)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 2 days to 1 week old

Volunteers: No Healthy Volunteers

Inclusion criteria

• birth weight between 500g to <1250g
• gestational age </= 32 weeks
• birth weight between 3rd to 97th percentile for gestational age
• survival to >48 hr age
• at least one parent speaks English or a language spoken by study investigator
• twins eligible if BOTH meet all criteria

Exclusion criteria

• chromosomal abnormalities
• major congenital anomalies
• maternal drug and /or alcohol use in pregnancy
• congenital infection
• decision made to withdraw intensive care treatments, or discussion about this already initiated with family

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)