The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

Infant, Premature Clinical Trial

— NIDCAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552383
• Other study ID #: 199700189 (AHFMR)
• Secondary ID: 199700189 (AHFMR
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: October 31, 2007
• Start date: September 1998
• Est. completion date: December 2004

Study information

• Verified date: October 2007
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Premature

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital, Neonatal Intensive Care Unit	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research, Canadian Lung Association

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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

External Links

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