Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group.
- Who it may be relevant to
- Registry conditions: Nutrition Intervention, Quality Improvement, Preterm Infant. Basic parameters: up to 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants Based on Best Clinical Practice: a Real Word Study
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07538999 · ENM2026