Nutrition and Growth in Very Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature, Growth

Intervention / Treatment
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* Other: Oral nutritional intake


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| very preterm infants cohort<br>A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months. | Other: Oral nutritional intake<br>* 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.<br>* Other names: C-peptide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-scores of weight | Computed according to the Fenton preterm growth standards (2013) | at corrected age 40 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-scores of length/height | Computed according to the Fenton preterm growth standards (2013) | at corrected age 40 gestational weeks | 
| Z-scores of head circumference | Computed according to the Fenton preterm growth standards (2013) | at corrected age 40 gestational weeks | 
| Z-scores of weight | Computed according to the WHO standards (2006) | at corrected age 6 months and 18 months | 
| Z-scores of length/height | Computed according to the WHO standards (2006) | at corrected age 6 months and 18 months | 
| Z-scores of head circumference | Computed according to the WHO standards (2006) | 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). | at corrected age 6 months and 18 months | 
| Body fat free mass | assessed by air displacement plethysmography (ADP) | at corrected age 40 gestational weeks and 6 months | 
| Body fat mass | assessed by air displacement plethysmography (ADP) | at corrected age 40 gestational weeks and 6 months | 
| Body fat proportion | assessed by air displacement plethysmography (ADP) | 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). | 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. | from birth to corrected age 18 months |