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

Peking University

Status: Enrolling

Conditions: Growth Retardation

Treatments: Other: (enteral feeding volume/ total fluid volume)*100%

Study type: Observational

Funder types: Other

Identifiers

NCT06071403

IRB00001052-23093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 416 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

416 participants in 3 patient groups

60-70% group

Description:

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

Treatment:

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

71-80% group

Description:

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

Treatment:

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

81-90% group

Description:

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

Treatment:

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