The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

NCT ID: NCT00552383

Last Updated: 2007-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30
• Study Completion Date: 2004-12-31

Brief 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

Keywords

Preterm Infant; Behaviour; Developmental Care; NIDCAP; Family Centred Care; Neurodevelopmental Outcome, preterm infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role: collaborator

Canadian Lung Association

INDUSTRY

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Principal Investigators

Kathrine L Peters, MN PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta, Faculty of Nursing

Locations

Royal Alexandra Hospital, Neonatal Intensive Care Unit

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 8078162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3786036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10617706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8591679 (View on PubMed)

Related Links

http://www.nidcap.com/

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

Other Identifiers

199700189 (AHFMR)

Identifier Type: -

Identifier Source: secondary_id

199700189 (AHFMR)

Identifier Type: -

Identifier Source: org_study_id