Nutrition and Growth in Very Preterm Infants

NCT04143204 | Completed

• 1 other identifier: NGPI2019
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature; Growth

Outcome Measures

Primary Outcomes (1)

• Z-scores of weight

  Computed according to the Fenton preterm growth standards (2013)

  at corrected age 40 gestational weeks

Secondary Outcomes (11)

• Z-scores of length/height

  at corrected age 40 gestational weeks

• Z-scores of head circumference

  at corrected age 40 gestational weeks

• Z-scores of weight

  at corrected age 6 months and 18 months

• Z-scores of length/height

  at corrected age 6 months and 18 months

• Z-scores of head circumference

  at corrected age 6 months and 18 months

Study Arms (1)

very preterm infants cohort

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

Other: Oral nutritional intake

Interventions

Oral nutritional intake 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.

Also known as: All nutritional intake, Insulin-like growth factor 1, Leptin, Ghrelin, C-peptide

very preterm infants cohort

Eligibility Criteria

• Age: 1 Day - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Very preterm or very low birth weight infants in NICU

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Premature Birth

Interventions

Eating; Insulin-Like Growth Factor I; Leptin; Ghrelin; C-Peptide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Somatomedins; Insulin-Like Peptides; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors; Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Proinsulin; Insulins; Pancreatic Hormones

Study Officials

• Weili Yan, MD, PhD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: October 29, 2019
• Study Start: August 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)