Improving newborn survival in preterm birth

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008326
• Date of registration: 10-04-2017
• Prospective Registration: Yes
• Primary sponsor: World Health Organization
• Public title: Improving newborn survival in preterm birth
• Scientific title: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes - Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns (ACTION-I TRIAL)
• Date of first enrolment: 01-06-2017
• Target sample size: 6120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17527
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Bangladesh, India, Kenya, Nigeria, Pakistan

Contacts

• Name: Dr Shivaprasad S Goudar
• Affiliation: KLE Univeristys J N Medical College

• Name: Dr Shivaprasad S Goudar
• Affiliation: KLE Univeristys J N Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Trial participants will be pregnant women coming to the hospital for delivery. Participants will be eligible for the trial if

1 Birth planned or expected within 48 hours

2 Gestational age from 26 weeks 0 days to 33 weeks 6 days

3 Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive

4 Women with no clinical signs of severe infection (as per clinical assessment)

5 Women willing and able to provide consent

Women with the following conditions are eligible. Any comorbid conditions will be managed according to local guidelines,and in line with WHO recommendations:

6 Women with a history of previous preterm birth

7 Women with hypertensive disorders

8 Women with a growth impaired fetus

9 Women with pre-gestational or gestational diabetes

10 Women with HIV/AIDs
Exclusion criteria: 1 Intrauterine fetal death

2 Major or lethal congenital fetal anomaly identified

3 Clinical suspicion or evidence of clinical chorioamnionitis, as per obstetric care physician assessment

4 Clinical suspicion or evidence of severe infection, as per obstetric care physician assessment

5 No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible

6 Any concurrent or recent (within the past 2 weeks) systemic corticosteroid use during the current pregnancy (outside of trial)

7 Unwilling or unable to provide consent

Currently a participant in another clinical trial related to maternal and neonatal health

8 Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Prevention of neonatal deaths by administration of Antenatal Corticosteroids to women with a live fetus/es at risk of imminent preterm birth from 26 weeks 0 days to 33 weeks 6 days gestation Health Condition 2: P220- Respiratory distress syndrome of newborn

Intervention(s)

Intervention1: Dexamethasone: A single course of 6mg IM dexamethasone administered every 12 hours, to a total of four (4) doses (time points 0 hours, 12 hours, 24 hours and 36 hours)
Control Intervention1: Identical placebo: A single course of 6mg IM Identical placebo administered every 12 hours, to a total of four (4) doses (time points 0 hours, 12 hours, 24 hours and 36 hours)

Primary Outcome(s)

1. Neonatal death: death of a live birth within 28 completed days of life.

2. Stillbirth or neonatal death: Any death of a fetus (post enrolment) or death of a live birth within 28 completed days of life among all enrolled participants

3. Possible maternal bacterial infection: Occurrence of maternal fever, or clinically suspected or confirmed infection, for which therapeutic antibiotics were used.Timepoint: Randomization to 28 days postpartum

Secondary Outcome(s)

Non-obstetric infection (excluding malaria)Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Maternal fever â?¥38.0 C after enrolment (on any one occasion during hospital admission)Timepoint: Randomization to 28 days postpartum

Process of care outcomes

Mother:

1. Measure of care given to woman:

Therapeutic antibiotics for suspected or confirmed infection (obstetric or non-obstetric)

Number of days of therapeutic antibiotic use

Any antibiotic use (prophylactic or therapeutic)

Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Severe neonatal respiratory distressTimepoint: birth to 28 days of life (during initial postnatal hospitalization only)

Process of care outcomes

Neonate:

1. Measures of care given to neonate

Major neonatal resuscitation at birth

Timing of breast milk feeding initiation

Use and length of oxygen therapy

Use and length of continuous positive airway pressure (CPAP) ventilation

Use and length of mechanical ventilation (MV)

Use and length of parenteral antibiotic therapy

Use and doses of surfactant treatmentTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Stillbirth (post enrolment)Timepoint: randomization to birth

Maternal death (from time of enrolment to 28 completed days)Timepoint: randomization to 28 days postpartum

Severe intraventricular haemorrhage (sIVH)Timepoint: birth, up to 7 days of life or discharge

Apgar score at 5 minutesTimepoint: first 5 minutes of life

Early neonatal deathTimepoint: birth to 7 completed days of life

Neonatal hypoglycaemiaTimepoint: birth to 28 days of life (during initial postnatal hospitalization only)

Postpartum endometritisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Process of care outcomes

Mother:

3. Compliance measures

Compliance with study allocation

Use of repeat course

Total number of ACS doses received (initial and repeat)

Time from initiation of first dose (ACS or placebo) to birth (days)Timepoint: Randomization until birth

ChorioamnionitisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Neonatal sepsisTimepoint: birth to 28 days of life (during initial postnatal hospitalization only)

Process of care outcomes

2.Health service utilization

Length of hospital stay after birth

Admission to a special care unit

Length of admission to special care unit (days)

Readmission for health care at the facility

Length of readmission (days)

Number of readmissions to health facility

Cause of readmission to health facilityTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Wound infectionTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Process of care outcomes

Mother:

2. Health service utilization

Mean length of total maternal hospitalization for delivery (days)

Any postpartum maternal readmission to facility (within 28 completed days of delivery)

Number of maternal readmissions to facility

Cause of maternal readmission to facility

Any referral of woman to another facility for treatment of complications

Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only)

Secondary ID(s)

A65913 version1.10, 6 February 2017

ACTRN12617000476336

Source(s) of Monetary Support

World Health Organization Department of Reproductive Health and Research 20 Avenue Appia CH 1211 Geneva 27 Switzerland

Ethics review

Status: Approved
Approval date: 27/02/2017
Contact:

JNMC Institutional Ethics Committee on Human Subjects Research KLESs Jawaharlal Nehru Medical College Belgaum

Status: Approved
Approval date: 15/03/2017
Contact:

Institutional Ethical Committee BLDE Universitys Shri B M Patil Medical College

Status: Approved
Approval date: 30/03/2017
Contact:

Institutional Ethics Committee of S Nijalingappa Medical College and Hanagal Shri Kumareshwar Hospital and Research Centre Bagalkot

Status: Approved
Approval date: 24/04/2018
Contact:

Institutional Ethics Committee SCB Medical College Cuttack