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NCT Number: NCT07538999

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

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.

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Key information

Conditions

Nutrition Intervention Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Quality Improvement Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location status: Recruiting

Location contact

Junyan Han, Doctor

CONTACT

[email protected]

86 13524675569

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

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

Junyan Han, Doctor

CONTACT

[email protected]

86 13524675569

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 20, 2026
Registry last updated
Jul 6, 2026

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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