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

Conditions: gastroesophageal reflux in preterm newborns
MedDRA version: 9.1Level: LLTClassification code 10038262Term: Reflux esophagitis

Registration Number: EUCTR2008-001526-13-IT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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),

Secondary Outcome Measures