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Completed

NCT Number: NCT04143204

Nutrition and Growth in Very Preterm Infants

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.

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Key information

Conditions

Premature Female Urogenital Diseases and Pregnancy Complications Growth Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral nutritional intake

Other

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

Primary outcomes

  1. Z-scores of weight

    Time frame: at corrected age 40 gestational weeks

    Computed according to the Fenton preterm growth standards (2013)

Secondary outcomes

  1. Z-scores of length/height

    Time frame: at corrected age 40 gestational weeks

    Computed according to the Fenton preterm growth standards (2013)

  2. Z-scores of head circumference

    Time frame: at corrected age 40 gestational weeks

    Computed according to the Fenton preterm growth standards (2013)

  3. Z-scores of weight

    Time frame: at corrected age 6 months and 18 months

    Computed according to the WHO standards (2006)

  4. Z-scores of length/height

    Time frame: at corrected age 6 months and 18 months

    Computed according to the WHO standards (2006)

  5. Z-scores of head circumference

    Time frame: at corrected age 6 months and 18 months

    Computed according to the WHO standards (2006)

  6. Percentage of infants who achieve catch-up growth

    Time frame: 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).

  7. Body fat free mass

    Time frame: at corrected age 40 gestational weeks and 6 months

    assessed by air displacement plethysmography (ADP)

  8. Body fat mass

    Time frame: at corrected age 40 gestational weeks and 6 months

    assessed by air displacement plethysmography (ADP)

  9. Body fat proportion

    Time frame: at corrected age 40 gestational weeks and 6 months

    assessed by air displacement plethysmography (ADP)

  10. Cognitive development outcome

    Time frame: 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).

  11. Intestinal flora change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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