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

Study Overview
=================
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: to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight; to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight; to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.

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

Conditions
-----------------
Growth Retardation

Intervention / Treatment
-----------------
* Other: (enteral feeding volume/ total fluid volume)*100%


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 60-70% group<br>We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). | Other: (enteral feeding volume/ total fluid volume)*100%<br>* (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume<br>|
| 71-80% group<br>We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). | Other: (enteral feeding volume/ total fluid volume)*100%<br>* (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume<br>|
| 81-90% group<br>We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). | Other: (enteral feeding volume/ total fluid volume)*100%<br>* (enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |