Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology

Not Applicable

Completed

• Conditions: Pain Score
• Interventions: Other: the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal; Other: the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier

• Registration Number: NCT03142230
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn

Detailed Description

After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn

Study Timeline

• Study Start: 2016-10-14
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
• Presence of sucking reflex
• Patient whose authors of parental authority have given their written consent for their participation
• Patient affiliated to or benefiting from a social security scheme

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Exclusion Criteria

• Newborn intubated or NIV and / or sedated
• Newborn with malformation (especially cleft palate)
• Contra-indication to sugar administration
• Newborn previously included in the study
• Administration of analgesics in the previous 8 hours
• Atresia of the unoperated esophagus
• Non-operated oeso-tracheal fistula
• Major swallowing disorders
• Necrotizing ulcerative colitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-nutritive suction with holed baby bottle nipple	the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal	A group using the holed baby bottle nipple
Simple non-nutritive suction with personal pacifier	the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier	A group using personal pacifier

Primary Outcome Measures

Name	Time	Method
pain evaluation	Time of nurse care - thirty minutes maximum	DAN SCALE

Trial Locations

Locations (3)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France

Centre Hospitalier de Saint-Denis; 🇫🇷 Saint-Denis, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France