The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care - Full Text View

Sponsor:	University of Alberta
Collaborators:	Alberta Heritage Foundation for Medical Research Canadian Lung Association
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00552383

Purpose

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.

Condition	Intervention
Infant, Premature	Procedure: NIDCAP based developmental care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Length of hospital stay [ Time Frame: Sept 1999 to Dec 2002 ]

Secondary Outcome Measures:

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 [ Time Frame: sept 1999 - dec 2002 ]
Maternal Stress [ Time Frame: Sept 1999 - Dec 2002 ]
incidence of Apnea of Prematurity [ Time Frame: sept 1999 - dec 2002 ]
time to regain birthweight [ Time Frame: sept 1999 - dec 2002 ]
time to attain full enteral feeds [ Time Frame: sept 1999 - dec 2002 ]
incidence of intracranial hemorrhage and periventricular leukomalacia [ Time Frame: sept 1999 - dec 2002 ]

Enrollment:	120
Study Start Date:	September 1998
Study Completion Date:	December 2004

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	up to 1 Week
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552383

Locations

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

Sponsors and Collaborators

University of Alberta

Alberta Heritage Foundation for Medical Research

Canadian Lung Association

Investigators

Principal Investigator:

Kathrine L Peters, MN PhD

University of Alberta, Faculty of Nursing

More Information

Additional Information:

the NIDCAP education and training program is described; accredited NIDCAP training centres are listed here also This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

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. Erratum in: Clin Pediatr (Phila) 1996 Mar;35(3):172.

ClinicalTrials.gov Identifier:	NCT00552383 History of Changes
Other Study ID Numbers:	199700189 (AHFMR), 199700189 (AHFMR)
Study First Received:	October 31, 2007
Last Updated:	October 31, 2007
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

Preterm Infant
Behaviour
Developmental Care

NIDCAP
Family Centred Care
Neurodevelopmental Outcome, preterm infant

ClinicalTrials.gov processed this record on May 15, 2012