Research of Systemic Management for Late Preterm Infants Nutrition in China

Not Applicable

• Conditions: Late Premature Infants; Systemic Nutritional Management
• Interventions: Procedure: new systemic nutrition management protocol

• Registration Number: NCT02605577
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

The research content of the project includes three parts:

1. Investigation on nutritional status of late preterm infants.

2. Setting up systemic nutritional management of late preterm infants

3. 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.

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Study Start: 2016-01
• Last Update Posted: 2016-01-01
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	new systemic nutrition management protocol	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 this"new systemic nutritional management protocol" )

Primary Outcome Measures

Name	Time	Method
days of postnatal life when enteral nutrition reaching 120kcal/kg/d	29 months
length gain(cm/week)	29 months
weight gain(g/kg/week)	29 months
circumference gain(cm/week)	29 months

Secondary Outcome Measures

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