The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
1 other identifier
observational
416
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedOctober 6, 2023
October 1, 2023
1 year
September 25, 2023
October 4, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
60-70% group
We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\*100%).
71-80% group
We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\*100%).
81-90% group
We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\*100%).
Interventions
(enteral feeding volume/ total fluid volume)\*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume
Eligibility Criteria
Very low birth weight infants(birth weight less than 1500 grams)
You may qualify if:
- Infants with a birth weight less than 1500 grams
- Infants admitted within 72 hours after birth
- Infants born from July 1, 2023, to June 30, 2024
- Written informed consent from parents or guardians
You may not qualify if:
- Infants with congenital abnormality
- Infants surviving \<7 days after birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wei Guo
Xingtai, Hebei, China
Biospecimen
The serum will be used to test the concentration of insulin-like growth factor 1.
Study Officials
- STUDY CHAIR
Shuaijun Li, doctor
Peking University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctor, Attending physician
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 6, 2023
Study Start
July 1, 2023
Primary Completion
June 30, 2024
Study Completion (Estimated)
September 30, 2026
Last Updated
October 6, 2023
Record last verified: 2023-10