Effects of Non-Nutritive Sucking on Gastroesophageal Reflux and Related Apneas in Symptomatic Preterm Infants

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Gastroesophageal RefluxApneasBradycardia
Interventions
DEVICE

Pacifier

The effect of NNS on GER features will be evaluated in preterm infants suffering from GER symptoms, for which a 24-hour pH-MII monitoring has been scheduled. During the monitoring period each infant will receive 8 meals: 4 meals will be followed by NNS, applied by pacifier, while the other 4 not. The sequence of NNS application will be consecutively alternated in study participants. At least 2 hours of NNS are required for the validity of each post-prandial evaluation; measures to fix the pacifier will be strictly forbidden. In the subgroup of babies with recurrent desaturations a simultaneous non-invasive 6-hour PSG monitoring comprehensive of 2 meals (one followed by NNS, the other not), will be performed to evaluate the effect of NNS on apneas, bradycardias and hypoxic episodes.

Trial Locations (1)

40138

Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital, Bologna

All Listed Sponsors
lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

NCT02023216 - Effects of Non-Nutritive Sucking on Gastroesophageal Reflux and Related Apneas in Symptomatic Preterm Infants | Biotech Hunter | Biotech Hunter