The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (enteral feeding volume/ total fluid volume)*100%.
- Who it may be relevant to
- Registry conditions: Growth Retardation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- short-term weight and long-term weight [Time frame: 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 [Time frame: 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 [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Infants with congenital abnormality
- Infants surviving <7 days after birth
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Wei Guo — Xingtai
Identifiers
NCT: NCT06071403 · IRB00001052-23093