The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

NCT00552383 | Completed

• 1 other identifier: 199700189 (AHFMR)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Sept 1999 to Dec 2002

Secondary Outcomes (10)

• 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

Interventions

NIDCAP based developmental care PROCEDURE

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 Criteria

• Age: 2 Days - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Heritage Foundation for Medical Research: collaborator
• Canadian Lung Association: collaborator

Study Sites (1)

Royal Alexandra Hospital, Neonatal Intensive Care Unit

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (4)

• 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.

  PMID: 8078162 BACKGROUND

• 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.

  PMID: 3786036 BACKGROUND

• 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.

  PMID: 10617706 BACKGROUND

• 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.

  PMID: 8591679 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Premature Birth; Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kathrine L Peters, MN PhD

  University of Alberta, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: September 1, 1998
• Study Completion: December 1, 2004
• Last Updated: November 1, 2007

Record last verified: 2007-10

Locations

CA (1)