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

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: Not yet recruiting
• Conditions: Quality Improvement; Preterm Infant; Nutrition Intervention
• Intervention / Treatment: Drug: A nutritional improving bundle for the intervention group; Drug: Routine nutritional strategies for the control group

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: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junyan Han, Doctor; Phone Number: 86 13524675569; Email: jyhan17@fudan.edu.cn

Study Locations

• China
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University
    • Contact: Junyan Han, Doctor; Phone Number: 86 13524675569; Email: jyhan17@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-score of weight	Computed according to the Fenton preterm growth chart (2025).	At discharge, approximately corrected gestational age of 36 to 42 weeks.
Z-score of length	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	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)	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)	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)	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	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	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	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	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	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	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

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: nutrition; growth; outcomes; preterm infants; zinc supplementation; bundle; carnitine supplementation; human milk feeding
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID 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