The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants

The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study

This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.

Study Overview

• Status: Recruiting
• Conditions: Growth Retardation
• Intervention / Treatment: Other: (enteral feeding volume/ total fluid volume)*100%

Detailed Description

At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.

Therefore, a prospective cohort study was designed with the aims:

1. to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
2. to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
3. to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.

• Study Type: Observational
• Enrollment (Estimated): 416

Contacts and Locations

• Study Contact: Name: Shuaijun Li, doctor; Phone Number: 18811331226; Email: 18811331226@163.com
• Study Contact Backup: Name: Shuag Zhou, doctor; Phone Number: 13296688543; Email: zhoushuang0601@bjmu.edu.cn

Study Locations

• China
  • He Bei
    • Xingtai, He Bei, China
      • Recruiting
      • Wei Guo
      • Contact: Wei Guo, Doctor; Phone Number: 13932903599; Email: guowei_xt@126.com
      • Contact: Yanguo Zhao, Master; Phone Number: 19831695015

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Very low birth weight infants(birth weight less than 1500 grams)

Description

Inclusion Criteria:

1. Infants with a birth weight less than 1500 grams
2. Infants admitted within 72 hours after birth
3. Infants born from July 1, 2023, to June 30, 2024
4. Written informed consent from parents or guardians

Exclusion Criteria:

1. Infants with congenital abnormality
2. Infants surviving <7 days after birth

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
60-70% group; We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%).	Other: (enteral feeding volume/ total fluid volume)*100%; (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume
71-80% group; We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%).	Other: (enteral feeding volume/ total fluid volume)*100%; (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume
81-90% group; We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%).	Other: (enteral feeding volume/ total fluid volume)*100%; (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short-term weight and long-term weight	weight	at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
short-term head circumference and long-term head circumference	head circumference	at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
short-term length and long-term length	length	at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Chair: Shuaijun Li, doctor, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: IRB00001052-23093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No