Protocol for Feeding Intolerance in Preterm Infants

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

Interventions

DIETARY_SUPPLEMENT

formula

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

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  lead OTHER

Principal Investigators

• qi lu, physician · Children's Hospital of Chongqing Medical University, Chongqing, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2024-05-31

Completion

2024-12-31

Countries

• China

Study Locations