NCT03359993

Brief Summary

The investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through Wharton's jelly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

November 28, 2017

Last Update Submit

January 25, 2022

Conditions

Infant Respiratory Distress Syndrome

Keywords

Endotracheal intubationNeonatal premedicationDelivery room

Outcome Measures

Primary Outcomes (1)

  • Conditions of intubation

    Classified from bad to excellent, depending on the neonates' residual tone, vocal chords mobility, and persistence of movements while inserting the tube.

    Seven months

Secondary Outcomes (1)

  • Duration of intubation

    Seven months

Study Arms (1)

Preterm infants intubated

All participants were preterm infants intubated in the delivery room for Infantile Respiratory Distress Syndrome (IRDS). The purpose of this research is to determine a premedication of intubation. This consists of describing a simple and effective method for premedication in the delivery room, using the umbilical vein, directly perforated through the Wharton jelly.

Procedure: Premedication of intubation

Interventions

Premedication of intubationPROCEDURE

The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. We used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. We report 5 cases of intubations in the delivery room using this method to administer the premedication.

Preterm infants intubated

Eligibility Criteria

AgeUp to 30 Minutes
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS)

You may qualify if:

  • All the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS).

You may not qualify if:

  • Refusal of legal owners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier René Dubos

Pontoise, 95390, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Suzanne BORRHOMEE

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 2, 2017

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 26, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)