The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Infant, Premature

Intervention / Treatment
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* Procedure: NIDCAP based developmental care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Sept 1999 to Dec 2002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maternal Stress |  | Sept 1999 - Dec 2002 | 
| incidence of Apnea of Prematurity |  | sept 1999 - dec 2002 | 
| time to regain birthweight |  | sept 1999 - dec 2002 | 
| time to attain full enteral feeds |  | sept 1999 - dec 2002 | 
| incidence of intracranial hemorrhage and periventricular leukomalacia |  | sept 1999 - dec 2002 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm Infant, Behaviour, Developmental Care, NIDCAP, Family Centred Care, Neurodevelopmental Outcome, preterm infant