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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pain Score

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, controlled, randomized, multicentric, open-label, randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-nutritive suction with holed baby bottle nipple<br>A group using the holed baby bottle nipple | 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<br>* The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple<br>|
| Active Comparator: Simple non-nutritive suction with personal pacifier<br>A group using personal pacifier | 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<br>* The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain evaluation | DAN SCALE | Time of nurse care - thirty minutes maximum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding tube, gastric, newborn infant, nursing, pain