Nutrition InterventionNCT07538999
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A study testing A nutritional improving bundle for the intervention group in people with Nutrition Intervention and Quality Improvement, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Nutrition Intervention, Quality Improvement, Preterm Infant
- What is being tested?
- A nutritional improving bundle for the intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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.
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- (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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Junyan Han, Doctor, 86 13524675569, jyhan17@fudan.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Being tested
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Keywords
- preterm infants, nutrition, bundle, zinc supplementation, carnitine supplementation, growth, outcomes, human milk feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nutritional improving bundle for the intervention groupDrug
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.
Routine nutritional strategies for the control groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Routine nutritional strategies for the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and at discharge, approximately corrected gestational age of 36 to 42 weeks
Secondary outcomes (12)
Z-score of weight
Computed according to the Fenton preterm growth chart (2025).
Measured: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Z-score of length
Computed according to the Fenton preterm growth chart (2025).
Measured: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Z-score of head circumference
Computed according to the Fenton preterm growth chart (2025).
Measured: At discharge, approximately corrected gestational age of 36 to 42 weeks.
The incidence of extrauterine growth retardation (EUGR)
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.
Measured: At discharge, approximately corrected gestational age of 36 to 42 weeks.
The incidence of bronchopulmonary dysplasia (BPD)
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.
Measured: At corrected gestational age 36 weeks.
The incidence of necrotizing enterocolitis (NEC)
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.
Measured: At discharge, approximately corrected gestational age of 36 to 42 weeks.
Time to achieve full enteral feeding
This refers to the time required to reach an enteral nutrition volume of 120 ml/kg.
Measured: At discharge, a corrected gestational age of approximately 36-42 weeks.
Neurodevelopmental outcomes
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).
Measured: At 12 months corrected age
Serum albumin level
The level of albumin in the blood biochemical test, expressed in units of g/L.
Measured: One week, one month, two months, three months after birth
The content of zinc in peripheral blood
The zinc content in peripheral blood was monitored using mass spectrometry, with the unit being umol/L.
Measured: One week, one month, two months, three months after birth.
The content of carnitine in peripheral blood
The carnitine content in peripheral blood was monitored using mass spectrometry, with the unit being uM.
Measured: One week, one month, two months, three months after birth.
Intestinal metabolic status
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.
Measured: Every week after birth until discharge, approximately corrected gestational age of 36 to 42 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition InterventionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The aim is to improve the growth outcomes of extremely and/or very preterm infants by optimizing the nutritional strategies
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538999
- Sponsor's protocol ID
- ENM2026
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants Based on Best Clinical Practice: a Real Word Study
- ClinicalTrials.gov ID
- NCT07538999
- Acronym / sponsor ID
- ENM2026
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Keywords
- preterm infants, nutrition, bundle, zinc supplementation, carnitine supplementation, growth, outcomes, human milk feeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aim is to improve the growth outcomes of extremely and/or very preterm infants by optimizing the nutritional strategies
| Arm | Type | Receives |
|---|---|---|
| Early Nutritional Improvement Group | Experimental | Drug: A nutritional improving bundle for the intervention groupThe 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. |
| Conventional Nutritional Strategies Group | Active comparator | Drug: Routine nutritional strategies for the control groupThe 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. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- (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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A nutritional improving bundle for the intervention groupThe 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. | Drug | Early Nutritional Improvement Group |
| Routine nutritional strategies for the control groupThe 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. | Drug | Conventional Nutritional Strategies Group |
Primary outcome
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).
12 secondary outcomes
Z-score of weight
Time frame: 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.
Z-score of head circumference
Time frame: 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 incidence of bronchopulmonary dysplasia (BPD)
Time frame: 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.
Time to achieve full enteral feeding
Time frame: At discharge, a corrected gestational age of approximately 36-42 weeks.
Neurodevelopmental outcomes
Time frame: At 12 months corrected age
Serum albumin level
Time frame: 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 content of carnitine in peripheral blood
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A nutritional improving bundle for the intervention group in people with Nutrition Intervention and Quality Improvement, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junyan Han, Doctor (86 13524675569, jyhan17@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.