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Not yet recruiting Not applicable NCT07538999

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

No applicable phase (e.g. observational)
Conditions: Nutrition Intervention Quality Improvement Preterm Infant

Sponsor: Children's Hospital of Fudan University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
A nutritional improving bundle for the intervention group
DRUG
Routine nutritional strategies for the control group
DRUG
Locations 1
China (1)
Children's Hospital of Fudan University
Shanghai
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Maximum age
1 Day
Healthy volunteers
No
Start date
01.04.2026
Completion date
31.12.2029
Registry ID
NCT07538999
Source
clinicaltrials.gov
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