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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06071403
Enrollment
416
Registered
2023-10-06
Start date
2023-07-01
Completion date
2026-09-30
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Retardation

Brief 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.

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.

Interventions

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

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
short-term weight and long-term weightat 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' ageweight
short-term head circumference and long-term head circumferenceat 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' agehead circumference
short-term length and long-term lengthat 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' agelength

Countries

China

Contacts

Primary ContactShuaijun Li, doctor
18811331226@163.com18811331226
Backup ContactShuag Zhou, doctor
zhoushuang0601@bjmu.edu.cn13296688543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026