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NCT Number: NCT06071403

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

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.

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Key information

Conditions

Growth Retardation

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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

    weight

  2. 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

    head circumference

  3. 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

    length

Study contacts

Contact information is provided by the study sponsor or research team.

Shuag Zhou, doctor

CONTACT

[email protected]

13296688543

Shuaijun Li, doctor

CONTACT

[email protected]

18811331226

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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