An observational study in Premature and Growth, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 1 Day to 18 Months. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Children's Hospital of Fudan University · Observational
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.
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.
Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
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Very preterm or very low birth weight infants in NICU
Exclusion Criteria:
A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months.
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.
Also known as: All nutritional intake, Insulin-like growth factor 1, Leptin, Ghrelin, C-peptide
Z-scores of weight
Computed according to the Fenton preterm growth standards (2013)
Time frame: at corrected age 40 gestational weeks
Z-scores of length/height
Computed according to the Fenton preterm growth standards (2013)
Time frame: at corrected age 40 gestational weeks
Z-scores of head circumference
Computed according to the Fenton preterm growth standards (2013)
Time frame: at corrected age 40 gestational weeks
Z-scores of weight
Computed according to the WHO standards (2006)
Time frame: at corrected age 6 months and 18 months
Z-scores of length/height
Computed according to the WHO standards (2006)
Time frame: at corrected age 6 months and 18 months
Z-scores of head circumference
Computed according to the WHO standards (2006)
Time frame: at corrected age 6 months and 18 months
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).
Time frame: at corrected age 6 months and 18 months
Body fat free mass
assessed by air displacement plethysmography (ADP)
Time frame: at corrected age 40 gestational weeks and 6 months
Body fat mass
assessed by air displacement plethysmography (ADP)
Time frame: at corrected age 40 gestational weeks and 6 months
Body fat proportion
assessed by air displacement plethysmography (ADP)
Time frame: at corrected age 40 gestational weeks and 6 months
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).
Time frame: at corrected age 18 months
Intestinal flora change
The change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.
Time frame: from birth to corrected age 18 months
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University