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Completed

NCT Number: NCT00552383

The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

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.

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Key information

Conditions

Infant, Premature Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Alexandra Hospital, Neonatal Intensive Care Unit

Edmonton, Alberta, T5H 3V9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Length of hospital stay

    Time frame: Sept 1999 to Dec 2002

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research
  • Canadian Lung Association

Registry information

Official study 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)

Acronym: NIDCAP

Important dates

Study start
1998
Study completion
2004
First posted
Nov 1, 2007
Registry last updated
Nov 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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