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

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ClinicalTrials.gov Identifier: NCT00552383
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : November 1, 2007
Alberta Heritage Foundation for Medical Research
Canadian Lung Association
Information provided by:
University of Alberta

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.

Condition or disease Intervention/treatment
Infant, Premature 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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : September 1998
Study Completion Date : December 2004

Intervention Details:
    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.

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Sept 1999 to Dec 2002 ]

Secondary Outcome Measures :
  1. Days of ventilation [ Time Frame: Sept 1999 to Dec 2002 ]
  2. Incidence of Chronic Lung Disease of Prematurity [ Time Frame: Sept 1999 to Dec 2002 ]
  3. Neurodevelopmental Disability at corrected age 18 months [ Time Frame: April 2001 to Dec 2004 ]
  4. incidence of sepsis [ Time Frame: Sept 1999 - Dec 2002 ]
  5. Use of sedative medication [ Time Frame: sept 1999 - dec 2002 ]
  6. Maternal Stress [ Time Frame: Sept 1999 - Dec 2002 ]
  7. incidence of Apnea of Prematurity [ Time Frame: sept 1999 - dec 2002 ]
  8. time to regain birthweight [ Time Frame: sept 1999 - dec 2002 ]
  9. time to attain full enteral feeds [ Time Frame: sept 1999 - dec 2002 ]
  10. incidence of intracranial hemorrhage and periventricular leukomalacia [ Time Frame: sept 1999 - dec 2002 ]

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552383

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
Principal Investigator: Kathrine L Peters, MN PhD University of Alberta, Faculty of Nursing

Additional Information:
ClinicalTrials.gov Identifier: NCT00552383     History of Changes
Other Study ID Numbers: 199700189 (AHFMR)
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by University of Alberta:
Preterm Infant
Developmental Care
Family Centred Care
Neurodevelopmental Outcome, preterm infant