|- candidate number||1444|
|- NTR Number||NTR258|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||ZonMw number: 2100.0072 |
|- Public Title||The prevention of developmental and behavioral problems of very preterm infants and parental stress through the use of development care: An intervention program for infants and parents. |
|- Scientific Title||The prevention of developmental and behavioral problems of very preterm infants and parental stress through the use of development care: An intervention program for infants and parents.|
|- ACRONYM||LDCS (the Leiden Developmental Care Study)|
|- hypothesis||Developmental care has a positive outcome on the development and behavior of very preterm infants and parental stress. |
|- Healt Condition(s) or Problem(s) studied||Brace, Preterm neonates, Premature infants|
|- Inclusion criteria||All premature infants with a gestational age of 32 weeks or less admitted to the neonatal intensive care unit of LUMC and JKZ hospitals in the health region of Leiden, Delft, The Hague and Gouda for a period of at least 5 days.|
|- Exclusion criteria||Infants of drug-addicted mothers and infants with cardiac problems or other major birth anomalies, or those requiring surgery.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2000|
|- planned closingdate||1-dec-2006|
|- Target number of participants||360|
|- Interventions||Two interventions (randomized control trials) in two consecutive phases:|
Reducing environmental stress through the use of covers over the incubators to decrease excess light and sound, the use of positional aids such as boundary supports and nests to promote a balance of flexion and extension. Versus standard care.
The use of the NIDCAP® behavioral assessment to create individual careplans for each infant and increasing parents' knowledge of premature infant behavior and more directly involving them in the care of their baby. Versus phase 1 intervention care.
|- Primary outcome||During hospital admission:|
Number of days requiring mechanical ventilation, CPAP or oxygen therapy;
number of days with reported apnea episodes; growth (weekly weight gain and increase of head circumference) morbidity
Parental Stress Scale-NICU (PSS-NICU), The Nurse Parent Support Tool (NPST) and Mothers and Babies Scale (MABS).
The infants participating in the study are examined at term age and after 1 and 2 years in the follow-up clinics of the LUMC and JKZ.
At term age:
A full medical history (including behavior) and physical examination, growth parameters, Prechtl neurological assessment and cerebral ultrasound.
At 1 year of age (corrected for prematurity):
Medical examination and growth parameters (weight, length and head circumference). Touwen neurological assessment.
Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSID II). Behavioral outcomes will be assessed through a parental questionnaire (ITSEA). Parental stress through the Nijmeegse parental stress index (NOSI(K)) questionnaire and Health Related Quality of life through the (TAPCQOL) questionnaire.
- At 2 years of age (corrected for prematurity):
Medical examination and growth parameters (weight, length and head circumference). Hempel neurological assessment.
- Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSIDII).
- Behavioral outcomes will be assessed through the CBCL(Child Behavior list), parental stress through the NOSI(K)-Nijmeegse parental stress index and Health Related Quality of life through the (TAPCQOL) questionnaires.
In phase 2; 2 additional questionnaires:
- 3 months: condition of infant (baby-KIPPPI)
- 9 months: infant behavior (IBQ).
|- Secondary outcome||After inclusion of both interventions in the 2 phases a self-made questionnaire was given to the nursing and medical staff to assess the implementation of the NIDCAP intervention. |
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. Celeste Maguire|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Celeste Maguire|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Pediatrics|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||This study explores the effects of the basic elements of developmental care (standardized nests and covers; phase 1) and the effect of the NIDCAP observation and guidance program (phase 2) on the development and behavior of very preterm infants and on parental stress. Outcomes include follow-up until 2 years of correced age. |
|- Main changes (audit trail)|
|- RECORD||7-sep-2005 - 14-sep-2009|