NCT02332304

Brief Summary

To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

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

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

January 4, 2015

Last Update Submit

January 4, 2015

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (1)

  • Respiratory Distress Syndrome, Newborn

    Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).

    1 month

Study Arms (1)

Preterm fetus

OTHER

Patients with pregnancies between 26 and 36 6/7 weeks of pregnancy. Before the birth, a sample of amniotic fluid was taken and analyzed using optical density at 650nm. A value above 0.15 was considered an indication of fetal lung maturity.

Procedure: Preterm fetus

Interventions

Preterm fetusPROCEDURE

A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.

Preterm fetus

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy between 26 and 36 6/7 weeks.

You may not qualify if:

  • Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Osvaldo Reyes, MD

    Saint Thomas Hospital, Panama

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

PA(1)