Research of Systemic Management for Late Preterm Infants Nutrition in China

Study Overview
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Brief Summary
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The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. And to compare the differences of growth and complications of these infants between groupings applicationg and not applicating the systemic nutritional management of late preterm infants,and to validate its feasibility and validity.

Detailed Description
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The research content of the project includes three parts: Investigation on nutritional status of late preterm infants. Setting up systemic nutritional management of late preterm infants Comparing nutritional and growth status of the late preterm, short-term and long-term complications between the groups applicating and not applicating the systemic nutritional management of late pretern infants.

Official Title
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Research of Systemic Management for Late Preterm Infants Nutrition in China

Conditions
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Late Premature Infants, Systemic Nutritional Management

Intervention / Treatment
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* Procedure: new systemic nutrition management protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants with gestational age 34 weeks to 36 weeks and 6 days Exclusion Criteria: preterm infants with gestational age<34 weeks or >36 weeks and 6 days abnormality of digestive system genetic and metablic disease severe congenital heart disease( with hemodynamic changes that influencing enteral feeding)
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>group of late preterm infants following new systemic nutritional management protocol during hospital stay,which including specific enteral and parenteral nutritional protocol and complication monitor, such as hyperglycemia,hypoglycemia,infection,hyperbilirubinemia and anemia(the intervention refers to thisnew systemic nutritional management protocol ) | Procedure: new systemic nutrition management protocol<br>* a new established systemic nutrition management protocol<br>|
| No Intervention: control group<br>group of late preterm infants using current nutritional management protocol during hospital stay | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of postnatal life when enteral nutrition reaching 120kcal/kg/d |  | 29 months | 
| weight gain(g/kg/week) |  | 29 months | 
| length gain(cm/week) |  | 29 months | 
| circumference gain(cm/week) |  | 29 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of postnatal life when reaching full enteral nutrion(d) | the incidence of complications of preterm infants | 29 months | 
| proportion of breast milk feeding(%) |  | 29 months | 
| days of postnatal life with the lowst weight during hospitalisation(d) |  | 29 months | 
| the lowest weight during hospitalisation(g) |  | 29 months | 
| days of postnatal life that regain birth weight(d) |  | 29 months | 
| incidence of hyperglycemia(%) |  | 29 months | 
| incidence of hypoglycemia(%) |  | 29 months | 
| incidence of hypebilirubinemia(%) |  | 29 months | 
| incidence of neonatal infection(%) |  | 29 months | 
| incidence of neonatal anemia(%) |  | 29 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late preterm infants, nutrition, systemic management