NCT01206946

Brief Summary

The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

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

September 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 23, 2011

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

September 21, 2010

Last Update Submit

June 22, 2011

Conditions

Respiratory Distress Syndrome, NewbornTransient Tachypnea of the Newborn

Keywords

Respiratory distressAntenatal steroidslate preterm

Outcome Measures

Primary Outcomes (1)

  • Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)

    First three days of life

Secondary Outcomes (11)

  • Admission to NICU

    First three days of life

  • Hospital stay

    Neonatal period (28 days of life)

  • Days on oxygen

    Neonatal period (28 days of life)

  • Intubations

    First three days of life

  • Surfactant treatment

    First three days of life

  • +6 more secondary outcomes

Study Arms (2)

Antenatal steroids

EXPERIMENTAL
Drug: Betamethasone

Normal saline

PLACEBO COMPARATOR
Other: Normal Saline

Interventions

BetamethasoneDRUG

A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

Antenatal steroids
Normal SalineOTHER

Two doses of 2ml of normal saline given at 24 hourly intervals

Normal saline

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 34 0/7- 36 6/7 weeks of gestation
  • High risk of preterm birth

You may not qualify if:

  • Multiple births
  • Fetal congenital malformations
  • A course of steroids within 2 weeks of randomization
  • Multiple courses of steroids
  • Chorioamnionitis
  • Non reassuring fetal heart rate
  • Obstetrical indication of delivery
  • Active bleeding
  • Pregnancy related hypertensive disorders
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Bahman Hospital

Beirut, Lebanon

RECRUITING

Hotel Dieu de France

Beirut, Lebanon

NOT YET RECRUITING

Rafik Hariri University Hospital

Beirut, Lebanon

RECRUITING

St Georges Hospital- University Medical Center

Beirut, Lebanon

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornTransient Tachypnea of the NewbornDyspnea

Interventions

BetamethasoneSaline Solution

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTachypneaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Khalid Yunis, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalid Yunis, MD

CONTACT

961-1-350000kayunis@aub.edu.lb

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 23, 2011

Record last verified: 2010-09

Locations

LE(5)