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.
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
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.
- Conditions
- Infant, Premature
- 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.
Length of hospital stay
Measured: Sept 1999 to Dec 2002
Secondary outcomes (10)
Days of ventilation
Measured: Sept 1999 to Dec 2002
Incidence of Chronic Lung Disease of Prematurity
Measured: Sept 1999 to Dec 2002
Neurodevelopmental Disability at corrected age 18 months
Measured: April 2001 to Dec 2004
incidence of sepsis
Measured: Sept 1999 - Dec 2002
Use of sedative medication
Measured: sept 1999 - dec 2002
Maternal Stress
Measured: Sept 1999 - Dec 2002
incidence of Apnea of Prematurity
Measured: sept 1999 - dec 2002
time to regain birthweight
Measured: sept 1999 - dec 2002
time to attain full enteral feeds
Measured: sept 1999 - dec 2002
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.
- First posted1 Nov 2007 (estimated)
- Study startSep 1998
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Canadian Lung Association
- Investigators
- Kathrine L Peters, MN PhD, Principal investigator, University of Alberta, Faculty of Nursing
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 8078162Als 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 3786036Westrup 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 10617706Fleisher 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00552383
- Acronym / sponsor ID
- NIDCAP / 199700189 (AHFMR)
- Conditions
- Infant, Premature
- Keywords
- Preterm Infant, Behaviour, Developmental Care, NIDCAP, Family Centred Care, Neurodevelopmental Outcome, preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Canadian Lung Association
- Study start
- Sep 1998
- Study completion
- Dec 2004 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 days to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIDCAP based developmental careInfants 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. | Procedure or surgery | – |
Primary outcome
Length of hospital stay
Time frame: Sept 1999 to Dec 2002
10 secondary outcomes
Days of ventilation
Time frame: Sept 1999 to Dec 2002
Incidence of Chronic Lung Disease of Prematurity
Time frame: Sept 1999 to Dec 2002
Neurodevelopmental Disability at corrected age 18 months
Time frame: April 2001 to Dec 2004
incidence of sepsis
Time frame: Sept 1999 - Dec 2002
Use of sedative medication
Time frame: sept 1999 - dec 2002
Maternal Stress
Time frame: Sept 1999 - Dec 2002
incidence of Apnea of Prematurity
Time frame: sept 1999 - dec 2002
time to regain birthweight
Time frame: sept 1999 - dec 2002
time to attain full enteral feeds
Time frame: sept 1999 - dec 2002
incidence of intracranial hemorrhage and periventricular leukomalacia
Time frame: sept 1999 - dec 2002
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
- Background: PubMed 8078162Als 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.
- Background: PubMed 3786036Als 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.
- Background: PubMed 10617706Westrup 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.
- Background: PubMed 8591679Fleisher 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.
- the NIDCAP education and training program is described; accredited NIDCAP training centres are listed here alsoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrine L Peters, MN PhD principal investigator
University of Alberta, Faculty of Nursing
1 site in 1 country: see every site and its status.
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.