The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

University of Alberta120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Infant, Premature

Interventions

NIDCAP based developmental carePROCEDURE

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.

Eligibility

Sex: ALLMin age: 2 DaysMax age: 1 Week

Medical Language ↔ Plain English

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

Locations (1)

Royal Alexandra Hospital, Neonatal Intensive Care Unit

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Length of hospital stay

Time frame: Sept 1999 to Dec 2002

Secondary Outcomes

Days of ventilation

Time frame: Sept 1999 to Dec 2002

Incidence of Chronic Lung Disease of Prematurity

Time frame: Sept 1999 to Dec 2002

Neurodevelopmental Disability at corrected age 18 months

Time frame: April 2001 to Dec 2004

incidence of sepsis

Time frame: Sept 1999 - Dec 2002

Use of sedative medication