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NCT05347706
Protocol for Feeding Intolerance in Preterm Infants
NA trial testing formula in Feeding Intolerance in 190 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Children's Hospital of Chongqing Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 1 March 2021 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- formula
Conditions studied
- Feeding Intolerance — all drugs for Feeding Intolerance →
- Preterm Infants — all drugs for Preterm Infants →
Sponsor
Children's Hospital of Chongqing Medical University
Who can join
Eligibility, any sex, with Feeding Intolerance or Preterm Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Amino Acid-Based Formula vs. Extensively Hydrolyzed Formula in the Treatment of Feeding Intolerance in Preterm Infants: Study Protocol for a Randomized Controlled Trial.
Zhong Q, Lu Q, Peng N, Liang XH. · · 2022 · cited 4× · PMID 35711561 · DOI 10.3389/fnut.2022.854121
Verify or expand the search:
- PubMed search for NCT05347706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of formula
Trials testing the same drug.
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Other recruiting trials for Feeding Intolerance
Currently open trials in the same condition.
- NCT06632314 — Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants · NA · active not recruiting
Other Children's Hospital of Chongqing Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05347706 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Chongqing Medical University
- Last refreshed: 26 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05347706.
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