Antenatal Dexamethasone for Late Preterm Deliveries

Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Respiratory Distress of Newborn
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Study design: The study is a double-blinded randomized controlled trial, parallel group. The sequence of randomization will be generated by using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists) with 2 groups of treatments with ratio 1:1, block of variable size (2,4,6), list length 302, no stratification. After having a randomization sequence, the symbol of group (control or intervention) will be kept in a sealed envelope. These envelops will be also put in the order as the allocation sequence. Assessors and investigators will be blinded to the group allocation.

Participants: 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.

Intervention: 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.

Comparison: Standard care. Outcomes: Primary outcome: Need for any respiratory support in first 72 hours, which is determined when babies need to be supported with 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%).

Sample size is 300 participants in 2 groups: intervention group and control group.

Place: The study will be conducted at Danang Hospital for Women and Children, Danang, Vietnam.

Eligibility of participants will be assessed at admission area of delivery department. One senior obstetrician will introduce the study to the patient by using the study information sheet. If the pregnant woman agrees to join in the research, the writen consent will be delivered to her and she will sign on it. When participants agrees, one sealed envelope with a number inside will be opened to allocate which group she involves. At that time, Eligibility criteria and Part 1 of the CRF will also be filled.

After randomization, pregnant women will be monitored at delivery rooms until delivery or c-section. After birth, both mother and baby will be closed monitored and assessed until transferred to post-natal wards or neonatal unit. Part 2. Labour and at birth Part 3. Newborn outcomes Part 4: Maternal outcomes will be collected.

If infants discharge before 28 days old, the follow-up section will be done at follow-up clinic of neonatal unit. Information about outcome (alive or death), any re-admission to hospital (number of time and reasons), and nutrition (types of milk (breast milk, formula milk or mix), feeding methods (breast feeding, bottle, tube/cup/spoon) will be collected for Part 5 of CRF.

• Study Type: Interventional
• Enrollment (Estimated): 294
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chau Le, PhD; Phone Number: +84905983797; Email: lhmchau@dhktyduocdn.edu.vn

Study Locations

• Vietnam
  • Da Nang, Vietnam, 550000
    • Recruiting
    • Danang HOspital for Women and Children
    • Contact: Danang HOspital for Women and Children; Phone Number: +84236 3957 777; Email: benhvienphusannhi@danang.gov.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 34+0/7 to 36+6/7 weeks
• Expected preterm delivery for any indications in the next 7 days.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone group; 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; Antenatal dexamethasone will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
No Intervention: Control group; Participants in the control group will be received standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal respiratory morbidities	Rate of respiratory morbidities: RDS, TTN, Surfactant administration, Need for mechanical ventilation, Apnea, BPD	From birth to 28 days of life or death
Neonatal co-morbidities	Rate of co-morbidities: resuscitation after birth, other morbidities: Hypoglycemia, Hypothermia, Early onset infection, Late onset infection, Jaundice need phototherapy, IVH, NEC, Admission to NICU, Neonatal mortality; average hospital days	From birth to 28 days of life or death
Neonatal treatment outcomes	Rate of admission to NICU, Neonatal mortality rate, average hospital days	From birth to 28 days of life or death
Maternal secondary outcomes	Rate of maternal post-partum infection, rate of c-section	First week after delievery
Maternal outcomes	Average hospital days	First week after delievery

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): March 28, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory distress; Late preterm infants
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 49/2566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No