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

NCT02023216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-10-15

No results posted yet for this study

Summary

Gastro-esophageal reflux (GER) is a common condition among preterm infants, due to several physiological promoting factors. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly applies conservative strategies, is currently considered the best choice to manage GER in the preterm population. Among the most common conservative strategies, postural measures seem to represent an effective measure to reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs), thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate. Hence, a possible effect of NNS on GER features might be hypothesized.

This observational, prospective and explorative study primarily aims to explore the effect of NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to evaluate, in the subgroup of patients with recurrent GER-related apneas, the effect of NNS on cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed apneas and detected by a simultaneous polysomnographic monitoring.

Conditions

  • Gastroesophageal Reflux
  • Apneas
  • Bradycardia

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.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Luigi T Corvaglia, AP · Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital, Bologna (Italy).

Eligibility

Min Age
7 Days
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023216 on ClinicalTrials.gov