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Clinical Trials/NCT04143204
NCT04143204
Completed
Not Applicable

Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study

Children's Hospital of Fudan University1 site in 1 country180 target enrollmentAugust 1, 2019
ConditionsPrematureGrowth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature
Sponsor
Children's Hospital of Fudan University
Enrollment
180
Locations
1
Primary Endpoint
Z-scores of weight
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.

Detailed Description

As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • infants born with a gestational age \>=28 weeks and \<32 weeks and/or a birth weight \>=1000g and \<1500g;
  • infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.

Exclusion Criteria

  • major congenital anomalies or heredity metabolic diseases;
  • severe disease or abdominal surgery during hospitalization;
  • death during hospitalization or discharge without medical advice;
  • small for gestational age.

Outcomes

Primary Outcomes

Z-scores of weight

Time Frame: at corrected age 40 gestational weeks

Computed according to the Fenton preterm growth standards (2013)

Secondary Outcomes

  • Z-scores of length/height(at corrected age 6 months and 18 months)
  • Cognitive development outcome(at corrected age 18 months)
  • Body fat free mass(at corrected age 40 gestational weeks and 6 months)
  • Z-scores of weight(at corrected age 6 months and 18 months)
  • Body fat mass(at corrected age 40 gestational weeks and 6 months)
  • Intestinal flora change(from birth to corrected age 18 months)
  • Z-scores of head circumference(at corrected age 6 months and 18 months)
  • Percentage of infants who achieve catch-up growth(at corrected age 6 months and 18 months)
  • Body fat proportion(at corrected age 40 gestational weeks and 6 months)

Study Sites (1)

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