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

NCT02686801 | Unknown

• 1 other identifier: OPTIPREMA
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Birth of Newborn

Keywords

nutrition; prematurity; body composition

Outcome Measures

Primary Outcomes (1)

• Fat free mass at discharge

  Fat-fee mass percentage at discharge by pediatric air-displacement plethysmography After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, pediatric air-displacement plethysmography is performed in the last week of hospitalization. Body composition estimation is completed by clinical and demographic data collection and collection of information about neonatal nutrition.

  pediatric air-displacement plethysmography measurement will be done at 36 to 40 weeks postconceptional age

Secondary Outcomes (6)

• Factors (clinical characteristics at birth and morbidity, feeding regimen) influencing body composition at discharge

  pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age

• Prediction of fat free mass at discharge

  pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age

• Anthropometric parameters at discharge and at 2 years

  measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age

• Body mass index at discharge and at 2 years

  measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age

• Fat free mass in preterm infants fed human milk fortified in an individualized way

  pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age

Eligibility Criteria

• Age: 1 Week - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital de la Croix-Rousse: lead

Study Sites (1)

Hopital de la croix rousse

Lyon, 69004, France

RECRUITING

Related Publications (1)

• Larcade J, Pradat P, Buffin R, Leick-Courtois C, Jourdes E, Picaud JC. Estimation of Fat-free Mass at Discharge in Preterm Infants Fed With Optimized Feeding Regimen. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):115-118. doi: 10.1097/MPG.0000000000001261.

  PMID: 27149252 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• jean-charles picaud, MD, PhD

  Hopital de la croix rousse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jean-charles picaud, MD, PhD

CONTACT

0033472001550; jean-charles.picaud@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of pediatrics

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 22, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

FR (1)