Effect of Antenatal Corticosteroids on Neonatal Morbidity.

NCT03446937 | Completed

• 1 other identifier: AhmaduBUTH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

Antenal corticosteroids; Late preterm delivery; Neonatal morbidity

Outcome Measures

Primary Outcomes (1)

• Neonatal Respiratory distress syndrome

  Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.

  Within the first 72 hours of life

Secondary Outcomes (3)

• Transient tachypnoea of the newborn:

  Within the first 72 hours after delivery/birth

• Admission into neonatal intensive care unit.

  Within the first 72 hours after delivery/birth

• 2. Admission into neonatal intensive care unit. Apnoea.

  Within the first 72 hours after delivery/birth

Study Arms (3)

Dexamethasone sodium phosphate injection

EXPERIMENTAL

Intervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China)

Drug: Dexamethasone Sodium Phosphate Injection

Betamethasone sodium phosphate injection

EXPERIMENTAL

Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0)

Drug: Betamethasone Sodium Phosphate Injection (Medication)

Water for injection

PLACEBO COMPARATOR

Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.

Drug: Water for injection

Interventions

Dexamethasone Sodium Phosphate Injection DRUG

Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart

Also known as: Pemadex

Dexamethasone sodium phosphate injection

Betamethasone Sodium Phosphate Injection (Medication) DRUG

betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart

Betamethasone sodium phosphate injection

Water for injection DRUG

Two doses of intramuscular injection of water for injection given 12 hours apart

Also known as: Juhel water for injection

Water for injection

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
• Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.

You may not qualify if:

• Evidence of Chrioamnionitis.
• Evidence of foetal distress.
• History of use of antenatal corticosteroids in index pregnancy.
• Women who do not give consent.

Sponsors & Collaborators

• Ahmadu Bello University Teaching Hospital: lead

Study Sites (1)

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, PMB 06, Nigeria

Location

Related Publications (1)

• Yahya A, Sulayman HU, Abdulkadir I, Lawal BB. Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial. Niger Med J. 2023 Oct 21;64(4):532-544. doi: 10.60787/NMJ-64-4-297. eCollection 2023 Jul-Aug.

  PMID: 38952884 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

dexamethasone 21-phosphate; betamethasone sodium phosphate; Dosage Forms; Water; Injections

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Anisah Yahya, MBBS

  Ahmadu Bello University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer I/Fellow

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 27, 2018
• Study Start: December 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be made available 6 months after completion and will be made available for 6 months
• Access Criteria: It will be shared on request

Locations

NG (1)