|- candidate number||2181|
|- NTR Number||NTR739|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||28-jul-2006|
|- Secondary IDs||N/A |
|- Public Title||Preterm INfants KnowLegde on Target height and outcomE.|
|- Scientific Title||Growth and development of high risk and low risk preterm infants.|
|- hypothesis||Growth and development of high risk and low risk preterm infants differ from children born at a normal gestational age. Perinatal riskfactors, development and growth of high risk and low risk preterm infants are different.|
|- Healt Condition(s) or Problem(s) studied||Low birth weight infants, Premature infants, Perinatal risk factors, Low risk preterm infants, Neurodevelopmental outcome, Growth, Developmental screening|
|- Inclusion criteria||All infants born before 36 completed weeks gestation in a well defined large region of the Netherlands in 2002 and 2003.|
|- Exclusion criteria||1. Major congenital malformations;|
2. congenital infections.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-okt-2005|
|- planned closingdate||31-dec-2010|
|- Target number of participants||2125|
|- Interventions||1. Measurement of growth parameters at the age of 3 years and nine months;|
2. Retrospective analysis medical records mother and child;
3. Questionnaires on development, behaviour socio-economic and medical conditions at 3 year and nine months and at the age of 5 years;
4. WISC-R intelligence test and movement ABC test between the age of 6 and 7 years.
|- Primary outcome||Neurodevelopment and growth.|
|- Secondary outcome||N/A|
|- Trial web site||http://www.pinkeltje-onderzoek.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. J.M. Kerstjens |
|- CONTACT for SCIENTIFIC QUERIES||Drs. J.M. Kerstjens |
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Beatrix Children's Hospital|
(Source(s) of Monetary or Material Support)
|Abbott, Cornelia foundation for the mentally handicapped child , Beatrix Children’s Hospital Groningen research fund , Anneke Bulk general child health care research fund , Friesland Foods units Western Europe and Enhanced Nutrition and Research(ENSU)|
|- Brief summary||Preterm infants born before 32 weeks of gestation are called high risk preterm infants (HRPI) and are known to be at high risk for growth and neuro-developmental disorders. Adequate catch up growth has a beneficial effect on developmental outcome. "Too much"catch up growth might lead to an increased risk for developing the metabolic syndrome. Perinatal risk facors that influence neurodevelopmental outcome in HRPI have been studied extensively.|
Low risk preterm infants (LRPI) born between 32 and 36 weeks of gestation have not been studied extensively, but a subgroup of these LRPI might be at an increased risk of developing growth and neurodevelopmental disorders as well.
Which perinatal risk factors influence the neurodevelopmental outcome and growth of LRPI is not known.
We will assess perinatal and postnatal risk factors, (including pregnancy and medication mother) growth parameters and neurodevelopmental outcome in HRPI and LRPI compared to controls.
We will also study the efficacy of a modified version of the Dutch Van Wiechen Developmental screenings test to identify preterm infants at a young age who are at high risk of neurodevelopmental problems at school age.
|- Main changes (audit trail)|
|- RECORD||28-jul-2006 - 6-mei-2008|