AzTrials
AzTrials

Infant, PrematureNIDCAPNCT00552383

The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

A study testing NIDCAP based developmental care in people with Infant, Premature, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 2 days to 1 week
Conditions the study is for
Infant, Premature
What is being tested?
NIDCAP based developmental care
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteCanada
Study dates
Sep 1998to Dec 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 days to 1 week
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Royal Alexandra Hospital, Neonatal Intensive Care Unit

    Edmonton, Alberta, T5H 3V9

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
NIDCAP based developmental care
Keywords
Preterm Infant, Behaviour, Developmental Care, NIDCAP, Family Centred Care, Neurodevelopmental Outcome, preterm infant
Medical subject headings
Premature Birth, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIDCAP based developmental careProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of hospital stay

    Measured: Sept 1999 to Dec 2002

Secondary outcomes (10)

  1. Days of ventilation

    Measured: Sept 1999 to Dec 2002

  2. Incidence of Chronic Lung Disease of Prematurity

    Measured: Sept 1999 to Dec 2002

  3. Neurodevelopmental Disability at corrected age 18 months

    Measured: April 2001 to Dec 2004

  4. incidence of sepsis

    Measured: Sept 1999 - Dec 2002

  5. Use of sedative medication

    Measured: sept 1999 - dec 2002

  6. Maternal Stress

    Measured: Sept 1999 - Dec 2002

  7. incidence of Apnea of Prematurity

    Measured: sept 1999 - dec 2002

  8. time to regain birthweight

    Measured: sept 1999 - dec 2002

  9. time to attain full enteral feeds

    Measured: sept 1999 - dec 2002

  10. incidence of intracranial hemorrhage and periventricular leukomalacia

    Measured: sept 1999 - dec 2002

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2007 (estimated)
  2. Study startSep 1998
  3. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00552383
Sponsor's protocol ID
199700189 (AHFMR)
Other IDs
199700189 (AHFMR)
Acronym
NIDCAP
Status last verified
Oct 2007
First submitted
31 Oct 2007
Last updated
1 Nov 2007
Results posted
No
Data monitoring committee
No

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.

    PubMed 8078162

  • 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.

    PubMed 3786036

  • 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.

    PubMed 10617706

  • 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.

    PubMed 8591679

Questions about this trial

What is this clinical trial studying?

A study testing NIDCAP based developmental care in people with Infant, Premature, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of hospital stay (time frame: Sept 1999 to Dec 2002). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00552383, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2007.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in