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

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2008年6月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI