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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04143204
Enrollment
180
Registered
2019-10-29
Start date
2019-08-01
Completion date
2022-10-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Premature

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.

Interventions

OTHEROral 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.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Z-scores of weightat corrected age 40 gestational weeksComputed according to the Fenton preterm growth standards (2013)

Secondary

MeasureTime frameDescription
Z-scores of head circumferenceat corrected age 40 gestational weeksComputed according to the Fenton preterm growth standards (2013)
Z-scores of weightat corrected age 6 months and 18 monthsComputed according to the WHO standards (2006)
Percentage of infants who achieve catch-up growthat corrected age 6 months and 18 monthsCatch-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 free massat corrected age 40 gestational weeks and 6 monthsassessed by air displacement plethysmography (ADP)
Z-scores of length/heightat corrected age 40 gestational weeksComputed according to the Fenton preterm growth standards (2013)
Body fat proportionat corrected age 40 gestational weeks and 6 monthsassessed by air displacement plethysmography (ADP)
Cognitive development outcomeat corrected age 18 monthsIt 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).
Intestinal flora changefrom birth to corrected age 18 monthsThe change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.
Body fat massat corrected age 40 gestational weeks and 6 monthsassessed by air displacement plethysmography (ADP)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026