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

Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071403
• Other study ID #: IRB00001052-23093
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: October 2023
• Source: Peking University
• Contact: Shuaijun Li, doctor
• Phone: 18811331226
• Email: 18811331226[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Growth Retardation

Intervention

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

Locations

Country	Name	City	State
China	Wei Guo	Xingtai	He Bei

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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