Nutrition and Growth in Very Preterm Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Growth; Premature
• Intervention / Treatment: Other: Oral nutritional intake

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Very preterm or very low birth weight infants in NICU

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: All nutritional intake; Insulin-like growth factor 1; Leptin; Ghrelin; C-peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-scores of weight	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-scores of length/height	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks
Z-scores of head circumference	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks
Z-scores of weight	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Z-scores of length/height	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Z-scores of head circumference	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Percentage of infants who achieve catch-up growth	Catch-up growth is defined as weight, length/height or head circumference equal to or above the 25th percentile for corrected age, according to the WHO standards (2006).	at corrected age 6 months and 18 months
Body fat free mass	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Body fat mass	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Body fat proportion	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Cognitive development outcome	It is examined by six areas of development measured by Griffith Mental Development Scales (GMDS) including locomotor, personal-social, hearing and language, eye and hand co-ordination, performance and practical reasoning. Developmental impairment is defined as a developmental quotient lying one standard deviation below the mean (<85) and includes mild impairments (70-84) and moderate/severe impairment (<70).	at corrected age 18 months
Intestinal flora change	The change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.	from birth to corrected age 18 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): October 31, 2022
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: October 26, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: NGPI2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No