Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
(1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
(2) Death or discharge within two weeks after birth.
(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.
Trial design
Design model
Single group
Treatments tested in this trial
A nutritional improving bundle for the intervention group
DrugThe 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
DrugThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Early Nutritional Improvement GroupExperimental treatment 1 intervention
Group B: Conventional Nutritional Strategies GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
At baseline and at discharge, approximately corrected gestational age of 36 to 42 weeksSecondary outcomes
1
Z-score of weight
Computed according to the Fenton preterm growth chart (2025).
Time frame
At discharge, approximately corrected gestational age of 36 to 42 weeks.2
Z-score of length
Computed according to the Fenton preterm growth chart (2025).
Time frame
At discharge, approximately corrected gestational age of 36 to 42 weeks.3
Z-score of head circumference
Computed according to the Fenton preterm growth chart (2025).
Time frame
At discharge, approximately corrected gestational age of 36 to 42 weeks.4
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.
Time frame
At discharge, approximately corrected gestational age of 36 to 42 weeks.Sponsors and contacts
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Source ClinicalTrials.gov