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

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.

Study Overview

• Status: Unknown
• Conditions: Late Premature Infants; Systemic Nutritional Management
• Intervention / Treatment: Procedure: new systemic nutrition management protocol

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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" )	Procedure: new systemic nutrition management protocol; a new established systemic nutrition management protocol
No Intervention: control group; group of late preterm infants using current nutritional management protocol during hospital stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Peking University First Hospital; Peking University People's Hospital; Beijing Friendship Hospital; Beijing Ditan Hospital; Beijing 302 Hospital; Peking University Third Hospital; Beijing Chao Yang Hospital; Beijing Hospital; Beijing Anzhen Hospital; China-Japan Friendship Hospital; Beijing Children's Hospital; Navy General Hospital, Beijing; Beijing Haidian Maternal and Child Health Hospital; Beijing Obstetrics and Gynecology Hospital; Capital Institute of Pediatrics, China; Civil Aviation General Hospital; People's Hospital of Beijing Daxing District; Beijing Huaxin Hospital; Bayi Children's Hospital Affiliated to Beijing Military Gen Hospital; Beijing Shangdi Hospital; Beijing Tongzhou District Maternal and Child Health Hospital; Beijing Yanqing County Hospital; Military 301 Hospital; Beijing Chaoyang District Maternal and Child Health Hospital; Military 306 Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: nutrition; late preterm infants; systemic management
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: SMFLPIN