Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Neonatal Respiratory Distress Syndrome Clinical Trial

Official title:

Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446937
• Other study ID #: AhmaduBUTH
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Ahmadu Bello University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will be a double blind randomised controlled trial. There will be two study groups and one control group.

The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.

The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.

The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Evidence of Chrioamnionitis.

• Evidence of foetal distress.

• History of use of antenatal corticosteroids in index pregnancy.

• Women who do not give consent.

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Dexamethasone Sodium Phosphate Injection
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
• Betamethasone Sodium Phosphate Injection (Medication)
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
• Water for injection
Two doses of intramuscular injection of water for injection given 12 hours apart

Locations

Country	Name	City	State
Nigeria	Ahmadu Bello University Teaching Hospital Shika-Zaria	Zaria	Kaduna

Sponsors (1)

Lead Sponsor	Collaborator
Ahmadu Bello University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transient tachypnoea of the newborn:	As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital	Within the first 72 hours after delivery/birth
Secondary	Admission into neonatal intensive care unit.	As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital	Within the first 72 hours after delivery/birth
Secondary	2. Admission into neonatal intensive care unit. Apnoea.	As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital	Within the first 72 hours after delivery/birth