|- candidate number||23346|
|- NTR Number||NTR5563|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2015|
|- Secondary IDs||NL50800.094.14 METC Noord-Holland|
|- Public Title||Intake and growth in late preterms|
|- Scientific Title||Intake and growth in late preterms|
|- ACRONYM||moderately late preterms|
|- hypothesis||Moderately preterm infants (gestational age 32-36 weeks) show impaired growth and increased morbidities such as behavioural problems and developmental delays compared to term infants. They have not been routinely followed and it has been thought that they were at a relatively low risk of developing neurological abnormalities. There are no prospective studies performed in these infants to determine wheter suboptimal intakes in feeding and/or impaired growth play a role in these morbidities.|
|- Healt Condition(s) or Problem(s) studied||Growth, Preterm neonates, Nutrition|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
- born between 32 and 35 6/7 weeks of gestational age
- will not be transferred to an other hospital before discharge
- will visit the Outpatient Clinic of the Northwest Hospital Group in Alkmaar after discharge
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
- congenital abnormalities of the gastro-intestinal tract
- cardiac abnormalities
- metabolic or chromosomal/syndromal diseases
- infants that develop necrotising enterocolitis stage IIb or III (NEC)
- infants with chronical diseases that influence growth: e.g. coeliac disease, hypothyroidism, growth hormone deficiency, malabsorption, cow milk allergy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2016|
|- planned closingdate||1-feb-2018|
|- Target number of participants||200|
|- Interventions||The study will be an open, non-therapeutic exploratory study. The intake of fat, protein and calories will be collected in all infants born 32-36 weeks born or transferred to the neonatology ward of the Northwest Hospital Group in Alkmaar that are being followed at the Northwest Hospital Group Outpatient Clinic in Alkmaar. Prospective data on intake and growth will be collected as routine assessment until the age of 2 years. At the age of 2 years, a developmental test (BSID III) and a body composition measurement by using stable isotopes (single labeled water method) will be performed in the subjects whom parents consented.|
|- Primary outcome||1.To prospectively obtain the (parenteral/enteral) intake of protein, fat, carbohydrates and calories in moderately preterm infants (32-36 weeks) and obtain prospectively growth data in the first 2 years of life.|
2. What is the growth pattern in these late preterms in the first 2 years of life?
|- Secondary outcome||3. What is the body composition and the developmental outcome of late preterms at the age of 2 years?|
4.1s there a relationship between 1;the intake of protein, fat and carbohydrates and 2; growth?
5. Is there a relation betvveen 1; the intake of protein, fat and carbohydrates and 3, the body composition and developmental outcome?
|- Timepoints||The study will be an open, non-therapeutic exploratory study. The intake of fat, protein and calories win be collected in all infants born 32-36 weeks at or transferred to the neonatology ward of the Northwest Hospital Group in Alkmaar . The data of actual intake will be collected daily during the stay at the Neonatology ward of the Northwest Hospital Group in Alkmaar and the growth data will be collected during the weekly feeding round that is performed at the Neonatology ward. When infants are discharged, they will be followed at the Outpatient ward of the Northwest Hospital Group in Alkmaar at age term, 6 weeks corercted age, 3 months, 6 months, 1 year and 2 years corrected age. The data will be anonymously imported in a data base.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr
|- CONTACT for SCIENTIFIC QUERIES||Dr
|- Sponsor/Initiator ||Noordwest Ziekenhuisgroep|
(Source(s) of Monetary or Material Support)
|Nutricia Nederland B.V.|
|- Brief summary||Moderately preterm infants (gestational age 32-36 weeks) show impaired growth and increased morbidities such as behavioural problems and developmental delays compared to term infants. They have not been routinely followed and it has been thought that they were at a relatively low risk of developing neurological abnormalities. There are no prospective studies performed in these infants to determine whether suboptimal intakes in feeding and impaired growth might play a role in these morbidities.|
The first objective is to prospectively determine the intake of protein, fat, carbohydrates and calories from birth to the age of 2 years and correlate them with the postnatal growth until the age of 2 years. The second objective is to determine the motor and mental development in these infants by correlating the intake and growth to a Bayley Scales of Infant development (BSID-III) which is used to determine developmental delays in extremely preterm infants. The third objective is to determine whether the intake and growth in the first 2 years of life influences the body composition.
|- Main changes (audit trail)|
|- RECORD||2-nov-2015 - 14-feb-2016|