Protocol for Feeding Intolerance in Preterm Infants

NCT05347706 | Unknown

• 1 other identifier: interventional68/2021
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Feeding Intolerance; Preterm Infants

Keywords

feeding intolerance; preterm infant; amino acid-based formula; extensively hydrolyzed formula; randomized controlled trial; protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Duration of vomiting and abdominal distension

  through study completion, an average of 3 months

• Gastric residual volume

  up to 3 months

• Body weight during hospitalization

  through study completion, an average of 3 months

• Body length during hospitalization

  through study completion, an average of 3 months

• Head circumference during hospitalization

  through study completion, an average of 3 months

Study Arms (2)

AAF-fed group

EXPERIMENTAL

Amino Acid-Based Formula(NeocateⓇ; Nutricia, London, UK)

Dietary Supplement: formula

EHF-fed group

EXPERIMENTAL

Extensively Hydrolyzed Formula(AlfareⓇ; Nestle, Netherlands)

Dietary Supplement: formula

Interventions

formula DIETARY_SUPPLEMENT

Enteral feeding is started with in the first 24 hours of life. Human milk is encouraged, and preterm formula is fed when human milk is not available due to mother's or family's condition. Patients with feeding intolerance are temporarily fed with AAF or EHF instead of human milk or preterm formula. Once the patients with feeding intolerance show clinical improvement, AAF or EHF feeding is discontinued, and the previous feeding, either human milk or preterm formula is resumed

AAF-fed group; EHF-fed group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (1)

• Zhong Q, Lu Q, Peng N, Liang XH. Amino Acid-Based Formula vs. Extensively Hydrolyzed Formula in the Treatment of Feeding Intolerance in Preterm Infants: Study Protocol for a Randomized Controlled Trial. Front Nutr. 2022 May 30;9:854121. doi: 10.3389/fnut.2022.854121. eCollection 2022.

  PMID: 35711561 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• qi lu, physician

  Children's Hospital of Chongqing Medical University, Chongqing, China

  STUDY DIRECTOR

Central Study Contacts

qi lu, physician

CONTACT

17323880467; qilu_qi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded. A nutritionist who is not directly involved in inpatient care will prepare and label the formula with the participant's randomization number, date and time feeding, then deliver the formula to the nurse caring for the infant. The medical and nursing teams caring for the infants will be unaware of the type of formula used for feeding. The trial statistician will perform data analysis and be kept unaware of treatment group assignment until the results are finalized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 26, 2022
• Study Start: March 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (1)