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

July 2, 2026 updated by: Children's Hospital of Fudan University

Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants Based on Best Clinical Practice: a Real Word Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Compared with full-term infants, preterm infants, especially extremely and/or very preterm infants, have fewer nutritional reserves and higher nutritional demands. If their nutritional intake is insufficient, they are more likely to suffer from nutritional deficiencies, which can affect the development of important organs during critical periods. According to a study by the Chinese neonatal network (CHNN) in 2019, the overall incidence of postnatal growth restriction (PGR) among extremely and very preterm infants in 57 NICUs in China was 19.9%. A large number of studies have confirmed that early postnatal nutritional insufficiency or growth retardation is significantly associated with adverse outcomes such as long-term growth disorders, insufficient bone mineralization, and neurodevelopmental disorders. At the same time, some chronic diseases are also related to early nutritional imbalance. Therefore, optimizing the nutritional support strategies for extremely and/or very preterm infants during the early postnatal period has a crucial impact on improving their short-term and long-term outcomes. The current study is based on the best clinical practice evidence, integrating both parenteral nutrition and enteral nutrition. A quality improvement bundle is developed on nutrition supplementary, including individualized and precise human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation. These interventions aim to improve the clinical outcomes of extremely and/or very preterm infants, including their growth and development, organ function, and neurodevelopmental outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for intervention group:

  • (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.
  • (4) Obtained informed consent from family members. Exclusion Criteria for intervention group
  • (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
  • (2) Death or discharge within two weeks after birth.

Inclusion Criteria for control group:

  • (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.
  • (3) Admitted to the study center within 24 hours after birth. Exclusion Criteria for control group
  • (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
  • (2) Death or discharge within two weeks after birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Nutritional Improvement Group
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
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.
Active Comparator: Conventional Nutritional Strategies Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The z-score of weight change from birth to discharge
Time Frame: At baseline and at discharge, approximately corrected gestational age of 36 to 42 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Z-score of weight
Time Frame: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Computed according to the Fenton preterm growth chart (2025).
At discharge, approximately corrected gestational age of 36 to 42 weeks.
Z-score of length
Time Frame: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Computed according to the Fenton preterm growth chart (2025).
At discharge, approximately corrected gestational age of 36 to 42 weeks.
Z-score of head circumference
Time Frame: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Computed according to the Fenton preterm growth chart (2025).
At discharge, approximately corrected gestational age of 36 to 42 weeks.
The incidence of extrauterine growth retardation (EUGR)
Time Frame: At discharge, approximately corrected gestational age of 36 to 42 weeks.
The proportion of cases with EUGR among the research subjects.Extrauterine growth restriction is diagnosed using both cross-sectional and longitudinal criteria. The cross-sectional criterion is defined as weight below the 10th percentile on the growth curve refer to the Fenton preterm growth chart for the same postmenstrual age. The longitudinal criterion refers to a decrease in the z-score of more than 1.28 from birth to discharge.
At discharge, approximately corrected gestational age of 36 to 42 weeks.
The incidence of bronchopulmonary dysplasia (BPD)
Time Frame: At corrected gestational age 36 weeks.
The proportion of cases with BPD among the research subjects. The diagnostic criterion for BPD is that respiratory support is still required at a corrected gestational age of 36 weeks.
At corrected gestational age 36 weeks.
The incidence of necrotizing enterocolitis (NEC)
Time Frame: At discharge, approximately corrected gestational age of 36 to 42 weeks.
The proportion of cases with NEC among the research subjects.Neonatal necrotizing enterocolitis refers to NEC diagnosed as Stage II or greater according to the Bell's staging criteria.
At discharge, approximately corrected gestational age of 36 to 42 weeks.
Time to achieve full enteral feeding
Time Frame: At discharge, a corrected gestational age of approximately 36-42 weeks.
This refers to the time required to reach an enteral nutrition volume of 120 ml/kg.
At discharge, a corrected gestational age of approximately 36-42 weeks.
Neurodevelopmental outcomes
Time Frame: At 12 months corrected age
It is examined by Griffith Mental Development Scales (GMDS) Developmental impairment is defined as a developmental quotient lying one standard deviation below the mean (<85) and includes mild impairments (70-84) and moderate/severe impairment (<70).
At 12 months corrected age
Serum albumin level
Time Frame: One week, one month, two months, three months after birth
The level of albumin in the blood biochemical test, expressed in units of g/L.
One week, one month, two months, three months after birth
The content of zinc in peripheral blood
Time Frame: One week, one month, two months, three months after birth.
The zinc content in peripheral blood was monitored using mass spectrometry, with the unit being umol/L.
One week, one month, two months, three months after birth.
The content of carnitine in peripheral blood
Time Frame: One week, one month, two months, three months after birth.
The carnitine content in peripheral blood was monitored using mass spectrometry, with the unit being uM.
One week, one month, two months, three months after birth.
Intestinal metabolic status
Time Frame: Every week after birth until discharge, approximately corrected gestational age of 36 to 42 weeks.
Detection of intestinal metabolites, collection of fecal samples (once a week after admission), measurement of the content of components related to fatty acid metabolism in intestinal metabolites.
Every week after birth until discharge, approximately corrected gestational age of 36 to 42 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENM2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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