Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT05347706
Eligibility Criteria:
Inclusion Criteria:
* Admission between December 2021 and December 2023.
* Gestational age (GA) \< 32 weeks or birth weight (BW) \< 1500g, appropriate for gestational age, admitted to Department of neonatology, Children's Hospital of Chongqing Medical University within the first 24 h after birth, maximal enteral intake \< 50 mL/kg/day.
* Patients are fed with preterm formula when human milk is not available after admission.
* Meet the diagnostic criteria of feeding intolerance (FI). Currently, a clear and universal definition of FI is lacking, FI is defined as follows with reference to relevant literature：One or two of the criteria below are met: (1) gastric residual volume ≥ 50% of the previous feeding volume (≥ twice within 24 h), with the presentation of vomiting and/or abdominal distension; (2) feeding plans fail: including feeding withheld or decrease \> 6h, or not increased \> 24h.
* Parental consent has been obtained.
Exclusion Criteria:
* Perinatal asphyxia: (1) Apgar score less than four at five minutes; (2) Fetal umbilical artery acidemia: pH less than 7.00 and/or base deficit worse than or equal to minus 12 mmol/L; (3) A significant peripartum or intrapartum hypoxic-ischemic event (e.g., uterine rupture, placental abruption, cord prolapse, amniotic fluid embolism, fetal exsanguination from a vasa previa or massive feto-maternal hemorrhage, etc.).
* Potential metabolic or chronic disease, congenital abnormality or any other diseases that may affect feeding ability, normal growth, and development before recruitment.
* Patients who need surgical treatment under general anesthesia (ligation of patent ductus arteriosus is excluded) before or on the date of randomization.
* Blood pressure is unstable (allowing for dopamine \< 5ug/kg/min).
* Ventilator dependence or FiO2 \> 40% on the date of randomization (allowing for nasal intubation, CPAP, and/ or oxygen mask ).
* Grade III or IV intraventricular hemorrhage is diagnosed before or on the date of randomization.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05347706
Study Brief:
Protocol Section:
NCT05347706