Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants

NCT07538999 | Not Yet Recruiting

• 1 other identifier: ENM2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants. This bundle consists of three aspects: individualized and precise human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation.

Conditions

Nutrition Intervention; Quality Improvement; Preterm Infant

Keywords

preterm infants; nutrition; bundle; zinc supplementation; carnitine supplementation; growth; outcomes; human milk feeding

Outcome Measures

Primary Outcomes (1)

• The z-score of weight change from birth to discharge

  The difference between the z-score of weight at discharge and the z-score of weight at birth based on the fenton growth chart (2025).

  At baseline and at discharge, approximately corrected gestational age of 36 to 42 weeks

Secondary Outcomes (12)

• Z-score of weight

  At discharge, approximately corrected gestational age of 36 to 42 weeks.

• Z-score of length

  At discharge, approximately corrected gestational age of 36 to 42 weeks.

• Z-score of head circumference

  At discharge, approximately corrected gestational age of 36 to 42 weeks.

• The incidence of extrauterine growth retardation (EUGR)

  At discharge, approximately corrected gestational age of 36 to 42 weeks.

• The incidence of bronchopulmonary dysplasia (BPD)

  At corrected gestational age 36 weeks.

Study Arms (2)

Early Nutritional Improvement Group

EXPERIMENTAL

The intervention group will receive an additional nutritional bundle based on the routine nutritional strategies for the control group. The bundle includes individualized and precise human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation.

Drug: A nutritional improving bundle for the intervention group

Conventional Nutritional Strategies Group

ACTIVE COMPARATOR

The subjects of control group were retrospectively included using historical data, they only received the conventional nutritional strategies at that time without including the bundle of the intervention group.

Drug: Routine nutritional strategies for the control group

Interventions

A nutritional improving bundle for the intervention group DRUG

The intervention group will receive an additional nutritional bundle based on the routine nutritional strategies for the control group. The bundle include individualized and precise breastfeeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation.

Early Nutritional Improvement Group

Routine nutritional strategies for the control group DRUG

The control group consisted of retrospectively enrolled subjects matched with the intervention group. They received only the nutritional supplementation strategies routinely used in clinical practice at the time, including standard human milk fortification, zinc supplementation based on serological markers, and lower-dose carnitine supplementation.

Conventional Nutritional Strategies Group

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (1) Admitted to the Neonatal Department of Children's Hospital of Fudan University during the study period.
• (2) Preterm infants with a gestational age \< 32 weeks or a birth weight \< 1500 g.
• (3) Admitted to the study center within 24 hours after birth.

You may not qualify if:

• (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
• (2) Death or discharge within two weeks after birth.
• (1) Admitted to the Neonatal Department of Children's Hospital of Fudan University from January 2025 to December 2025.
• (2) Preterm infants with a gestational age \< 32 weeks or a birth weight \< 1500 g.
• (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
• (2) Death or discharge within two weeks after birth.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Junyan Han, Doctor

CONTACT

86 13524675569; jyhan17@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The aim is to improve the growth outcomes of extremely and/or very preterm infants by optimizing the nutritional strategies

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)