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Efficacy of Gaviscon in the treatment of gastroesophageal reflux in preterm newborns - NEO-08-02

Efficacy of Gaviscon in the treatment of gastroesophageal reflux in preterm newborns - NEO-08-02

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001526-13-IT
Enrollment
Unknown
Registered
2008-06-17
Start date
2008-06-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux in preterm newborns MedDRA version: 9.1 Level: LLT Classification code 10038262 Term: Reflux esophagitis

Interventions

Trade Name: GAVISCON*OS SOSP 500MG+267MG/1 Pharmaceutical Form: Oral suspension INN or Proposed INN: SODIO ALGINATO CAS Number: 9005-38-3 Concentration unit: g gram(s) Concentration type: equal Concen

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm infants (Gestational Age  33 weeks) on full enteral feeding with symptoms of gastroesophageal reflux (post-prandial desaturations and/or serious feeding difficulties with failure to thrive). Weight at the study time ≥1100 g. Parents? written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe chronic disease. Drugs: prokinetics and/or antacids Major congenital malformations. Necrotizing enterocolitis. Present infections. Severe clinical conditions which, according to the researcher judgement, do not indicate the inclusion in the study Use of experimental drugs in the two weeks before the inclusion in the study. Hypersensitivity to the experimental drug. Patients unable to follow the study protocol and to sign written informed consent. The consent must be signed also by parents/guardian or by the legal representative, if patients are underage or unable to give their consent. Underage patients and patients unable to give consent must sign the consent in so far as they can.

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the efficacy of Gaviscon in reducing the number, the duration and the height of GER episodes.;Secondary Objective: to evaluate the safety of Gaviscon in preterm newborns by the frequency of adverse events in the period of drug administration compared to the period drug-free.;Primary end point(s): La variabile primaria di efficacia e' la riduzione del numero, della durata e dell?altezza degli episodi di reflusso gastroesofageo (sia acido che non acido),—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026