Research of Systemic Management for Late Preterm Infants Nutrition in China (NLP)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Systemic Nutritional Management; Late Premature Infants

Treatments: Procedure: new systemic nutrition management protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02605577

SMFLPIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,000 participants in 2 patient groups

experimental group

Experimental group

Description:

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" )

Treatment:

Procedure: new systemic nutrition management protocol

control group

No Intervention group

Description:

group of late preterm infants using current nutritional management protocol during hospital stay