Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 199700189 (AHFMR) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alberta Heritage Foundation for Medical Research | OTHER |
| Canadian Lung Association | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIDCAP based developmental care | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Sept 1999 to Dec 2002 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathrine L Peters, MN PhD | University of Alberta, Faculty of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital, Neonatal Intensive Care Unit | Edmonton | Alberta | T5H 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8078162 | Background | 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. | |
| 3786036 | Background | 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. |
| Label | URL |
|---|---|
| the NIDCAP education and training program is described; accredited NIDCAP training centres are listed here also | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 10617706 | Background | 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. |
| 8591679 | Background | 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. |
| D000091642 | Urogenital Diseases |