Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Saint Thomas Hospital, Panama
Otherlead

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

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

Enrollment

200 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Preterm fetus

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Preterm fetus

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations