NCT00720252

Brief Summary

The purpose of this study is to measure prenatally with ultrasound the intratracheal flow volume displaced during breathing cycle in premature fetuses and to check whether a relationship exists between the inspired fluid and fetal lung maturation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

5.4 years

First QC Date

July 19, 2008

Last Update Submit

March 20, 2015

Conditions

Fetal Lung Maturity

Outcome Measures

Primary Outcomes (1)

  • To check whether a threshold exists between peak velocity and/or volume of fluid inspired by the fetus and lung maturation.

    end of the study

Study Arms (1)

A

EXPERIMENTAL
Device: Ultrasound

Interventions

UltrasoundDEVICE

To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.

A

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women delivering between 27 to 37 weeks.
  • Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.

You may not qualify if:

  • Major fetal malformation.
  • Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. OB/GYN, HaEmek Medical Center

Afula, 18100, Israel

Location

Related Publications (2)

  • Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available.

    PMID: 6368667BACKGROUND

  • Kalache KD, Chaoui R, Bollmann R. Doppler assessment of tracheal and nasal fluid flow during fetal breathing movements: preliminary observations. Ultrasound Obstet Gynecol. 1997 Apr;9(4):257-61. doi: 10.1046/j.1469-0705.1997.09040257.x.

    PMID: 9168577BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 19, 2008

First Posted

July 22, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

IL(1)