Clinical trial NCT00552383: The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Preterm Infant
Behaviour
Developmental Care
NIDCAP
Family Centred Care
Neurodevelopmental Outcome, preterm infant
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
name: Canadian Lung Association
First posted: 2007-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Sept 1999 to Dec 2002
Secondary outcomes:
measure: Days of ventilation
timeFrame: Sept 1999 to Dec 2002
measure: Incidence of Chronic Lung Disease of Prematurity
timeFrame: Sept 1999 to Dec 2002
measure: Neurodevelopmental Disability at corrected age 18 months
timeFrame: April 2001 to Dec 2004
measure: incidence of sepsis
timeFrame: Sept 1999 - Dec 2002
measure: Use of sedative medication
timeFrame: sept 1999 - dec 2002
measure: Maternal Stress
timeFrame: Sept 1999 - Dec 2002
measure: incidence of Apnea of Prematurity
timeFrame: sept 1999 - dec 2002
measure: time to regain birthweight
timeFrame: sept 1999 - dec 2002
measure: time to attain full enteral feeds
timeFrame: sept 1999 - dec 2002
measure: incidence of intracranial hemorrhage and periventricular leukomalacia
timeFrame: sept 1999 - dec 2002
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital, Neonatal Intensive Care Unit
state: Alberta
Study officials:
affiliation: University of Alberta, Faculty of Nursing
name: Kathrine L Peters, MN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.