Status:
UNKNOWN
Protocol for Feeding Intolerance in Preterm Infants
Lead Sponsor:
Children's Hospital of Chongqing Medical University
Conditions:
Feeding Intolerance
Preterm Infants
Eligibility:
All Genders
Phase:
NA
Brief Summary
Background: Feeding intolerance is a common problem in preterm infants, which is associated with increased risk of infections, prolonged hospitalization, and increased economic costs. When human milk ...
Detailed Description
Globally, approximately 15 million premature infants are born every year, with this number increasing progressively. Due to the immature digestive, absorptive, and immunologic functions, preterm infan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05347706
Start Date
March 1 2021
End Date
December 31 2024
Last Update
April 26 2022
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014