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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-14

Study Completion Date

2018-08-13

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

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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

Conditions

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Pain Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, controlled, randomized, multicentric, open-label, randomized study

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The statistician is not aware of the control and experimental arms, called arms A and B in the results he must analyze.

Study Groups

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non-nutritive suction with holed baby bottle nipple

A group using the holed baby bottle nipple

Group Type EXPERIMENTAL

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

Intervention Type OTHER

The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple

Simple non-nutritive suction with personal pacifier

A group using personal pacifier

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier

Interventions

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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

The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple

Intervention Type 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

The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier

Intervention Type OTHER

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

Minimum Eligible Age

2 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No