Body Composition at Discharge and Neurological Development at 2 Years in Very Preterm Infants (OPTIPREMA)

H

Hôpital de la Croix-Rousse

Status

Unknown

Conditions

Premature Birth of Newborn

Study type

Observational

Funder types

Other

Identifiers

NCT02686801
OPTIPREMA

Details and patient eligibility

About

This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.

Full description

Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Recent data from the literature show that it is possible - with appropriate nutritional care - to reduce the initial weight loss and to ensure that the growth deficit accumulated is then less important than was previously observed. The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (12-18 g/kg.day according to postconceptional age). Children often grow slowly during the first 10 days of life, so they accumulate a growth deficit that should be compensated secondarily. Therefore, optimum postnatal growth is 20 g/kg.day, rather than 15 g/kg.day. It is also important to assess the quality of growth, particularly fat free mass. The objective of nutritional care is dual: a sufficient weight gain (close to fetal growth rate) but also a relevant body composition. However, there is very little data on body composition of premature babies at discharge. It is now possible to measure quickly (one minute), simply and noninvasively using pediatric air-displacement plethysmography. Previous studies using more complex search techniques to implement (dual energy X-ray absorptiometry) showed excessive body fat at discharge in premature babies. Reference values collected using pediatric air-displacement plethysmography were published in 2011. Nutritional practices and strategies have significantly evolved in the past years to support such objectives: improvement of early parenteral nutrient intake, new fortifiers for human milk, new preterm formulas and early beginning of enteral nutrition. Individualized fortification of human milk helps to provide preterm infants with sufficient amount of nutrients. The modern nutritionnal care in preterm infants results in earlier and higher protein and energy intakes than previously performed. It improves some anthropometric parameters but little is know about body composition at discharge. Furthermore, exposition to high nutrients intake could lead to metabolic and hormonal imprinting with an increased risk of diabetes and cardio-vascular diseases in adulthood. OPTIPREMA aim to focus the link between nutrient intakes during hospitalization, body composition at discharge and relationship between fat free mass variations at discharge and neurodevelopment at 2 years.

Enrollment

400 estimated patients

Sex

All

Ages

1 week to 3 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm newborns (less or equal to 32 weeks gestation and / or birthweight less or equal to1500g).
  • Admitted in the Neonatal unit before day-of-life 7, staying at least 15 days in the unit, and discharged home at ≥ 35 weeks postconceptional age directly from the neonatal unit (no transfer)
  • Oral Parental consent

Exclusion criteria

  • Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography
  • Pathology inducing neurodevelopment troubles
  • Transfer in an other hospital before discharge
  • Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography

Trial contacts and locations

1

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Central trial contact

jean-charles picaud, MD, PhD

Data sourced from clinicaltrials.gov

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