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

NCT ID: NCT06071403

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

416 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Growth Retardation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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60-70% group

We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\*100%).

(enteral feeding volume/ total fluid volume)*100%

Intervention Type OTHER

(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%).

(enteral feeding volume/ total fluid volume)*100%

Intervention Type OTHER

(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%).

(enteral feeding volume/ total fluid volume)*100%

Intervention Type OTHER

(enteral feeding volume/ total fluid volume)\*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume

Interventions

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(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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Li Shuaijun

Postdoctor, Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuaijun Li, doctor

Role: STUDY_CHAIR

Peking University

Locations

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Wei Guo

Xingtai, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuaijun Li, doctor

Role: CONTACT

18811331226

Shuag Zhou, doctor

Role: CONTACT

13296688543

Facility Contacts

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Wei Guo, Doctor

Role: primary

13932903599

Yanguo Zhao, Master

Role: backup

19831695015

Other Identifiers

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IRB00001052-23093

Identifier Type: -

Identifier Source: org_study_id

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