NCT03142230

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

March 28, 2017

Last Update Submit

October 17, 2019

Conditions

Pain Score

Keywords

feeding tubegastricnewborn infantnursingpain

Outcome Measures

Primary Outcomes (1)

  • pain evaluation

    DAN SCALE

    Time of nurse care - thirty minutes maximum

Study Arms (2)

non-nutritive suction with holed baby bottle nipple

EXPERIMENTAL

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

Simple non-nutritive suction with personal pacifier

ACTIVE COMPARATOR

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

Interventions

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 pharyngealOTHER

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

non-nutritive suction 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 pacifierOTHER

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

Simple non-nutritive suction with personal pacifier

Eligibility Criteria

Age2 Days - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Centre Hospitalier de Saint-Denis

Saint-Denis, 93200, France

Location

Related Publications (1)

  • Darretain H, Laborne FX, Lagadec S, Garrigue B, Maillard F, Harbi F, Waszak P, Granier M, Galand N, Walter-Nicolet E, Razafimahefa H. An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial. J Perinat Neonatal Nurs. 2024 Oct-Dec 01;38(4):361-368. doi: 10.1097/JPN.0000000000000746. Epub 2024 Nov 7.

    PMID: 38833575DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michele Granier, MD

    Centre Hospitalier Sud Francilien

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician is not aware of the control and experimental arms, called arms A and B in the results he must analyze.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, controlled, randomized, multicentric, open-label, randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

May 5, 2017

Study Start

October 14, 2016

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations

FR(3)