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

Premature Birth of Newborn Clinical Trial

— OPTIPREMA  

Official title:

Determinants of Body Composition at Discharge and Fat-Free Mass as an Indicator of Neurological Development at 2 Years in Very Preterm Infants : OPTIPREMA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686801
• Other study ID #: OPTIPREMA
• Status: Recruiting
• Start date: April 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Hôpital de la Croix-Rousse
• Contact: jean-charles picaud, MD, PhD
• Phone: 0033472001550
• Email: jean-charles.picaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Locations

Country	Name	City	State
France	Hopital de la croix rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de la Croix-Rousse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Factors (clinical characteristics at birth and morbidity, feeding regimen) influencing body composition at discharge	Factors (nutritional and others) influencing body composition of preterm infants (<35 weeks gestation) at discharge. Analysis will focuss on condotions that could be influenced by neonatal care, such as weight gain.	pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Secondary	Prediction of fat free mass at discharge	Prediction of fat free mass at discharge from anthropometric data, nutritional intakes, and evolution during hospitalization.	pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Secondary	Anthropometric parameters at discharge and at 2 years	Relationship between anthropometric parameters and body composition at discharge and growth at 2 years	measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Secondary	Body mass index at discharge and at 2 years	Relationship betwen body mass index as an marker of body composition at discharge and growth at 2 years	measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Secondary	Fat free mass in preterm infants fed human milk fortified in an individualized way	Impact of optimized feeding regimen using adjustable individualized fortification of human milk on fat free mass at discharge	pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Secondary	Developmental score as measured by an appropriate neurodevelopmental test at 2 years	Children neurological development at 2 years old evaluated according to the follow-up routine evaluation or very low birth weight infants	Neurodevelopmental assessment at 2 years old