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

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

Study Overview

• Status: Completed
• Conditions: Pain Score
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph
  • Saint-Denis, France, 93200
    • Centre Hospitalier de Saint-Denis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 2 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: non-nutritive suction with holed baby bottle nipple; 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; The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple
ACTIVE_COMPARATOR: Simple non-nutritive suction with personal pacifier; 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; The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Collaborators: Centre National de Ressources de lutte contre la Douleur

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2016
• Primary Completion (ACTUAL): August 13, 2018
• Study Completion (ACTUAL): August 13, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pain; nursing; gastric; feeding tube; newborn infant
• Other Study ID Numbers: 2015-A00427-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No