Antenatal Dexamethasone for Late Preterm Deliveries

Sponsor

Chulalongkorn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05841121

Collaborator

(none)

294

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 placebo. 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress of Newborn Preterm Birth	Drug: Dexamethasone Other: Placebo	Phase 1

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. Participants, 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: Placebo. Placebo will be given by intramuscular injection of normal saline 1.2 milliliter at points of 0h,12h, 24h and 36h, like the schedule of dexamethasone.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

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.
Placebo Comparator: Control group Participants in the control group will be given placebo. Placebo will be given by intramuscular injection of normal saline 1.2 milliliter at points of 0h,12h, 24h and 36h, like the schedule of dexamethasone.	Other: Placebo Placebo will be given by intramuscular injection of normal saline 1.2 milliliter at points of 0h,12h, 24h and 36h.

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.

Placebo Comparator: Control group

Participants in the control group will be given placebo. Placebo will be given by intramuscular injection of normal saline 1.2 milliliter at points of 0h,12h, 24h and 36h, like the schedule of dexamethasone.

Other: Placebo

Placebo will be given by intramuscular injection of normal saline 1.2 milliliter at points of 0h,12h, 24h and 36h.

Outcome Measures

Primary Outcome Measures

Rate of respiratory support [First 72 hours of life]
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%).

Secondary Outcome Measures

Neonatal respiratory morbidities [From birth to 28 days of life or death]
Rate of respiratory morbidities: RDS, TTN, Surfactant administration, Need for mechanical ventilation, Apnea, BPD
Neonatal co-morbidities [From birth to 28 days of life or death]
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
Neonatal treatment outcomes [From birth to 28 days of life or death]
Rate of admission to NICU, Neonatal mortality rate, average hospital days
Maternal secondary outcomes [First week after delievery]
Rate of maternal post-partum infection, rate of c-section
Maternal outcomes [First week after delievery]
Average hospital days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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