Infant, Premature
Conditions
Keywords
Preterm Infant, Behaviour, Developmental Care, NIDCAP, Family Centred Care, Neurodevelopmental Outcome, preterm infant
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.
Interventions
PROCEDURENIDCAP 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.
Sponsors
Alberta Heritage Foundation for Medical Research
Canadian Lung Association
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 1 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay | Sept 1999 to Dec 2002 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Days of ventilation | Sept 1999 to 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 |
| Maternal Stress | Sept 1999 - Dec 2002 |
Countries
Canada
Outcome results
None listed