Clinical trial NCT04143204: Nutrition and Growth in Very Preterm Infants
Official title: Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature
Growth
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very preterm or very low birth weight infants in NICU

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.

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.

Primary outcomes:
measure: Z-scores of weight
timeFrame: at corrected age 40 gestational weeks
Secondary outcomes:
measure: Z-scores of length/height
timeFrame: at corrected age 40 gestational weeks
measure: Z-scores of head circumference
timeFrame: at corrected age 40 gestational weeks
measure: Z-scores of weight
timeFrame: at corrected age 6 months and 18 months
measure: Z-scores of length/height
timeFrame: at corrected age 6 months and 18 months
measure: Z-scores of head circumference
timeFrame: at corrected age 6 months and 18 months
measure: Percentage of infants who achieve catch-up growth
timeFrame: at corrected age 6 months and 18 months
measure: Body fat free mass
timeFrame: at corrected age 40 gestational weeks and 6 months
measure: Body fat mass
timeFrame: at corrected age 40 gestational weeks and 6 months
measure: Body fat proportion
timeFrame: at corrected age 40 gestational weeks and 6 months
measure: Cognitive development outcome
timeFrame: at corrected age 18 months
measure: Intestinal flora change
timeFrame: from birth to corrected age 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Weili Yan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: