The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care (NIDCAP)

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)

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature
• Intervention / Treatment: Procedure: NIDCAP based developmental care

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital, Neonatal Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	Sept 1999 to Dec 2002

Secondary Outcome Measures

Outcome Measure	Time Frame
Days of ventilation	Sept 1999 to Dec 2002
Incidence of Chronic Lung Disease of Prematurity	Sept 1999 to Dec 2002
Neurodevelopmental Disability at corrected age 18 months	April 2001 to Dec 2004
incidence of sepsis	Sept 1999 - Dec 2002
Use of sedative medication	sept 1999 - dec 2002
Maternal Stress	Sept 1999 - Dec 2002
incidence of Apnea of Prematurity	sept 1999 - dec 2002
time to regain birthweight	sept 1999 - dec 2002
time to attain full enteral feeds	sept 1999 - dec 2002
incidence of intracranial hemorrhage and periventricular leukomalacia	sept 1999 - dec 2002

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Heritage Foundation for Medical Research; Canadian Lung Association
• Investigators: Principal Investigator: Kathrine L Peters, MN PhD, University of Alberta, Faculty of Nursing

Publications and helpful links

General Publications

• Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
• Als H, Lawhon G, Brown E, Gibes R, Duffy FH, McAnulty G, Blickman JG. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics. 1986 Dec;78(6):1123-32.
• Westrup B, Kleberg A, von Eichwald K, Stjernqvist K, Lagercrantz H. A randomized, controlled trial to evaluate the effects of the newborn individualized developmental care and assessment program in a Swedish setting. Pediatrics. 2000 Jan;105(1 Pt 1):66-72. doi: 10.1542/peds.105.1.66.
• Fleisher BE, VandenBerg K, Constantinou J, Heller C, Benitz WE, Johnson A, Rosenthal A, Stevenson DK. Individualized developmental care for very-low-birth-weight premature infants. Clin Pediatr (Phila). 1995 Oct;34(10):523-9. doi: 10.1177/000992289503401003. Erratum In: Clin Pediatr (Phila) 1996 Mar;35(3):172.

Helpful Links

• the NIDCAP education and training program is described; accredited NIDCAP training centres are listed here also

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Estimate): November 1, 2007
• Last Update Submitted That Met QC Criteria: October 31, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Developmental Care; NIDCAP; Behaviour; Preterm Infant; Family Centred Care; Neurodevelopmental Outcome, preterm infant
• Other Study ID Numbers: 199700189 (AHFMR)