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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Days to 1 Week (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* birth weight between 500g to \<1250g
- •* gestational age \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
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: Sept 1999 to Dec 2002
Secondary Outcomes
- 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)