Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants Based on Best Clinical Practice: a Real Word Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The z-score of weight change from birth to discharge
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 1 Day (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •(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.
Arms & Interventions
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.
Intervention: A nutritional improving bundle for the intervention group (Drug)
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.
Intervention: Routine nutritional strategies for the control group (Drug)
Outcomes
Primary Outcomes
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
- Z-score of weight(At discharge, approximately corrected gestational age of 36 to 42 weeks.)
- Z-score of length(At discharge, approximately corrected gestational age of 36 to 42 weeks.)
- Z-score of head circumference(At discharge, approximately corrected gestational age of 36 to 42 weeks.)
- The incidence of extrauterine growth retardation (EUGR)(At discharge, approximately corrected gestational age of 36 to 42 weeks.)
- The incidence of bronchopulmonary dysplasia (BPD)(At corrected gestational age 36 weeks.)
- The incidence of necrotizing enterocolitis (NEC)(At discharge, approximately corrected gestational age of 36 to 42 weeks.)
- Time to achieve full enteral feeding(At discharge, a corrected gestational age of approximately 36-42 weeks.)
- Neurodevelopmental outcomes(At 12 months corrected age)
- Serum albumin level(One week, one month, two months, three months after birth)
- The content of zinc in peripheral blood(One week, one month, two months, three months after birth.)
- The content of carnitine in peripheral blood(One week, one month, two months, three months after birth.)
- Intestinal metabolic status(Every week after birth until discharge, approximately corrected gestational age of 36 to 42 weeks.)