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Completed

NCT Number: NCT03142230

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

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

Completed

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Key information

Conditions

Pain Score Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other

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

Primary outcomes

  1. pain evaluation

    Time frame: Time of nurse care - thirty minutes maximum

    DAN SCALE

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Collaborators

  • Centre National de Ressources de lutte contre la Douleur

Registry information

Acronym: DOLATSONG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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