Preterm Infants Clinical Trial
Official title:
Amino Acid-based Formula Versus Extensively Hydrolyzed Formula in the Treatment of Feeding Intolerance in Preterm Infants: Study Protocol for a Randomized Controlled Trial
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 is not available, formula feeding is required. Amino acid-based formula and extensively hydrolyzed formula could be considered to use for severe feeding intolerance. A recent Cochrane meta-analysis found that preterm infants fed extensively hydrolyzed formula compared with standard formula could not reduce the risk of feeding intolerance and necrotizing enterocolitis, and weight gain was slower. Some studies reported that preterm infants fed amino acid-based formula could reduce the gastric residual volume. Investigators hypothesize that amino acid-based formula can improve feeding intolerance and establish full enteral feeding more rapidly in preterm infants compared with extensively hydrolyzed formula. Method: The randomized, prospective, controlled trial is to be conducted in Children's Hospital of Chongqing Medical University (Chongqing, China). A total of 190 preterm infants with gestational age < 32 weeks or birth weight < 1500g and with a diagnosis of feeding intolerance will be included. Patients will be randomized to an amino acid-based formula-fed group and an extensively hydrolyzed formula-fed group. The primary outcome is the time (days) to reach full enteral feedings. Secondary outcomes include duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters and incidence of adverse events. Discussion: The successful implementation of the study will provide robust evidence for formula alternatives in preterm infants with feeding intolerance.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Chongqing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time (days) to reach full enteral feeding | defined as a daily intake of = 150 mL/Kg/day for three days in a row (age at the first day of achieving full enteral feedings as the indicator). | through study completion, an average of 3 months | |
Secondary | Duration of vomiting and abdominal distension | days | through study completion, an average of 3 months | |
Secondary | Gastric residual volume | ml; measured by aspirating with a 5 ml syringe before each feeding | up to 3 months | |
Secondary | Body weight during hospitalization | in kg | through study completion, an average of 3 months | |
Secondary | Body length during hospitalization | in cm | through study completion, an average of 3 months | |
Secondary | Head circumference during hospitalization | in cm | through study completion, an average of 3 months | |
Secondary | Length of hospital stay | days | through study completion, an average of 3 months | |
Secondary | Cost during hospital stay | yuan | through study completion, an average of 3 months | |
Secondary | Time of parenteral nutrition | days | through study completion, an average of 3 months | |
Secondary | Change in abdomen circumference | cm; measured at the specific time every day | up to 3 months | |
Secondary | White blood cell count | tested by an automatic biochemical analyzer | up to 3 months | |
Secondary | Hepatic functional markers test | such as ALT, AST;tested by an automatic biochemical analyzer | up to 3 months | |
Secondary | Serum electrolytes test | such as Na,K,Ca,Pi; tested by an automatic biochemical analyzer | up to 3 months | |
Secondary | Incidence of adverse events | through study completion, an average of 3 months |
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