The primary objectives of this study is to study the endocrine regulation of growth in preterm infants.Secondary objectives are to study the influence of the endocrine regulation and early nutritional intake on neurodevelopmental outcome, boneā¦
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are anthropometry (height, weight and body
proportions), body composition and growth-related endocrine parameters.
Secondary outcome
Psychomotor development, bone mineralization, lipid status and blood pressure
Background summary
Preterm infants are almost universally faced with postnatal growth restriction.
Preterm birth, as well as postnatal growth restriction, is associated with
impaired neurodevelopmental outcome. Furthermore preterm infants are prone to
develop risk factors for the onset of the metabolic syndrome. Postnatal growth
patterns, e.g. catch-up growth with rapid weight gain, have been associated
with an increased risk for the development of risk factors for the metabolic
syndrome. By limiting postnatal growth restriction early nutritional
interventions could be a key in improving long-term outcomes of preterm
infants. Indeed it has been shown that nutritional interventions can influence
neurodevelopment and the onset of risk factors for the metabolic syndrome.
Insulin-like growth factor I (IGF-I) is one of the key factors in the endocrine
regulation of growth. After birth IGF-I levels quickly drop as the placental
supply is suddenly disrupted, to then slowly be restored in preterm infants. We
hypothesize that IGF I has to reach a certain threshold before it can
effectively influence growth, which might explain the need for a high-energy
and high-nutrient diet in the early postnatal period. On the other hand, we
hypothesize that less energy- and nutrient-enrichment is required once IGF-I
passes the threshold concentration. At this level the maximum growth rate is
expected to be potentiated by IGF-I, reducing the need for extra nutrients and
potentially leading to increased fat deposition if diet enrichment is
continued. Nonetheless, currently there is no full understanding of the
endocrine regulation of growth in preterm infants.
Study objective
The primary objectives of this study is to study the endocrine regulation of
growth in preterm infants.
Secondary objectives are to study the influence of the endocrine regulation
and early nutritional intake on neurodevelopmental outcome, bone
mineralization, lipid profile and blood pressure in preterm infants.
Study design
Cohort study
Intervention
Infants will be randomized to either preterm follow-up formula or standard care
at a postmenstrual age of 32-33 weeks.
Study burden and risks
During hospitalisation infants will be subjected to weekly blood draws and
anthropometric measurements. Since these preterm infants will be admitted to
the Neonatal Intensive Care Unit (NICU)blood draws for research purposes will
be combined with blood sampling necessary for clinical care. Infants will be
followed up at the outpatient department at term age and 3, 6, 12 and 24 months
corrected age for continued anthropometric measurements, body composition and
bone mineralization measurements, blood pressure registration, neuropsychologic
assessment and a total of 2 blood draws. The burden of the intervention is
expected to be minimal and is anticipated to improve long-term outcomes
compared to standard care. Due to the nature of the study it is not feasible to
conduct the research in another group than preterm infants.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language.
2. Gestational age of 24 to 32 weeks.
3. Arterial catheter in situ.;In order to be eligible for cord blood analysis, a subject must meet all of the following criteria:
1. Gestational age of 24 to 42 weeks
2. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language.
Exclusion criteria
A substantial congenital anomaly based on a chromosomal or syndromal disorder with a known effect on growth and body composition.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 5311 |
CCMO | NL50196.029.14 |