Nutrition and Growth in Very Preterm Infants

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143204
• Other study ID #: NGPI2019
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Growth
• Premature

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-scores of weight	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks
Secondary	Z-scores of length/height	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks
Secondary	Z-scores of head circumference	Computed according to the Fenton preterm growth standards (2013)	at corrected age 40 gestational weeks
Secondary	Z-scores of weight	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Secondary	Z-scores of length/height	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Secondary	Z-scores of head circumference	Computed according to the WHO standards (2006)	at corrected age 6 months and 18 months
Secondary	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
Secondary	Body fat free mass	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Secondary	Body fat mass	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Secondary	Body fat proportion	assessed by air displacement plethysmography (ADP)	at corrected age 40 gestational weeks and 6 months
Secondary	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
Secondary	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