Nutrition and Growth in Very Preterm Infants

NCT ID: NCT04143204

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-10-31

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.

Conditions

Premature; Growth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

very preterm infants cohort

A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months.

Oral nutritional intake

Intervention Type: OTHER

The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.

Interventions

Oral nutritional intake

The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.

Intervention Type: OTHER

Other Intervention Names

All nutritional intake; Insulin-like growth factor 1; Leptin; Ghrelin; C-peptide

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weili Yan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

NGPI2019

Identifier Type: -

Identifier Source: org_study_id