Antenatal Dexamethasone for Late Preterm Deliveries

NCT05841121 | Recruiting Phase 1

• 1 other identifier: 49/2566
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal dexamethasone reduce admission to Neonatal Intensive Care Unit and length of hospital stay? Participants will be allocated into 2 groups: intervention with dexamethasone IM and control (standard care). Investigators will compare these two groups to see if antenatal dexamethasone reduces the need for respiratory support in late preterm infants, neonatal morbidities and mortality, admission to NICU and length of hospital stay.

Conditions

Respiratory Distress of Newborn; Preterm Birth

Keywords

Late preterm infants; Respiratory distress

Outcome Measures

Primary Outcomes (1)

• Rate of respiratory support

  Rate of babies requiring any respiratory support such as continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).

  First 72 hours of life

Secondary Outcomes (5)

• Neonatal respiratory morbidities

  From birth to 28 days of life or death

• Neonatal co-morbidities

  From birth to 28 days of life or death

• Neonatal treatment outcomes

  From birth to 28 days of life or death

• Maternal secondary outcomes

  First week after delievery

• Maternal outcomes

  First week after delievery

Study Arms (2)

Dexamethasone group

EXPERIMENTAL

The intervention is antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.

Drug: Dexamethasone

Control group

NO INTERVENTION

Participants in the control group will be received standard care.

Interventions

Dexamethasone DRUG

Antenatal dexamethasone will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• +0/7 to 36+6/7 weeks
• Expected preterm delivery for any indications in the next 7 days.

You may not qualify if:

• Fetal death
• Severe fetal malformation
• Twin or multiple pregnancy
• Maternal contraindication to dexamethasone: hypersensitive with steroids, any infection
• Severe maternal conditions such as eclampsia, cardiac arrest, antepartum hemorrhage due to placenta previa or abruption
• Delivery estimated within 2 hours: total cervical dilation
• Received steroids within 1 week

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Danang HOspital for Women and Children

Da Nang, 550000, Vietnam

RECRUITING

Related Publications (1)

• Le CHM, Tran HT, Huynh QK, Chaithongwongwatthana S. Impact of Antenatal Dexamethasone on Respiratory Outcomes in Late Preterm Infants in a Vietnamese Tertiary Hospital: A Randomised Controlled Trial. Acta Paediatr. 2025 Dec 26. doi: 10.1111/apa.70417. Online ahead of print.

  PMID: 41452963 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Premature Birth; Dyspnea

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Chau Le, PhD

CONTACT

+84905983797; lhmchau@dhktyduocdn.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 3, 2023
• Study Start: August 25, 2023
• Primary Completion: March 28, 2024
• Study Completion: April 30, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

VN (1)