Nutrition and Growth in Very Preterm Infants

Completed

• Conditions: Premature; Growth
• Interventions: Other: Oral nutritional intake

• Registration Number: NCT04143204
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-26
• Study First Posted: 2019-10-29
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
very preterm infants cohort	Oral nutritional intake	A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months.

Primary Outcome Measures

Name	Time	Method
Z-scores of weight	at corrected age 40 gestational weeks	Computed according to the Fenton preterm growth standards (2013)

Secondary Outcome Measures

Name	Time	Method
Z-scores of length/height	at corrected age 6 months and 18 months	Computed according to the WHO standards (2006)
Cognitive development outcome	at corrected age 18 months	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).
Body fat free mass	at corrected age 40 gestational weeks and 6 months	assessed by air displacement plethysmography (ADP)
Z-scores of weight	at corrected age 6 months and 18 months	Computed according to the WHO standards (2006)
Body fat mass	at corrected age 40 gestational weeks and 6 months	assessed by air displacement plethysmography (ADP)
Intestinal flora change	from birth to corrected age 18 months	The change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.
Z-scores of head circumference	at corrected age 6 months and 18 months	Computed according to the WHO standards (2006)
Percentage of infants who achieve catch-up growth	at corrected age 6 months and 18 months	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).
Body fat proportion	at corrected age 40 gestational weeks and 6 months	assessed by air displacement plethysmography (ADP)

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China