| CTRI Number |
CTRI/2023/06/053731 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on efficacy of Dexamethasone in prevention of transient tachypnoea of newborn |
|
Scientific Title of Study
|
A comparative study to show Dexamethasone is equally efficacious as Betamethasone on preventing transient tachypnea of newborn after elective caesarean section in early term newborn. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajai Sasi |
| Designation |
Pg resident of Paediatrics |
| Affiliation |
KMCT Medical college |
| Address |
Department of Paediatrics, KMCT Medical College, Mukkam, Kozhikode, Kerala
KMCT Medical college, Mukkam, Kozhikode, Kerala, 673602
Kozhikode
KERALA
673602
India |
| Phone |
8281674492 |
| Fax |
|
| Email |
ajaisasidr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajai Sasi |
| Designation |
Pg resident of Paediatrics |
| Affiliation |
KMCT Medical college |
| Address |
Department of Paediatrics, KMCT Medical college, Mukkam, Kozhikode, Kerala
KMCT Medical college, Mukkam, Kozhikode, Kerala, 673602
Kozhikode
KERALA
673602
India |
| Phone |
8281674492 |
| Fax |
|
| Email |
ajaisasidr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Jose |
| Designation |
Associate professor of paediatrics |
| Affiliation |
KMCT medical college |
| Address |
Department of Paediatrics, KMCT medical college, Mukkam, Kozhikode, Kerala
KMCT medical college, Mukkam, Kozhikode, Kerala, Pin 673602
Kozhikode
KERALA
673602
India |
| Phone |
8281674492 |
| Fax |
|
| Email |
drsoumyajose@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCT Medical college, Mukkam, Kozhikode district, Kerala, India, Pin 673602 |
|
|
Primary Sponsor
|
| Name |
KMCT MEDICAL COLLEGE |
| Address |
MUKKAM. KOZHIKODE, KERALA, INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Jose |
KMCT medical college |
Labour room 1 and Neonatal ICU 1, Mother and child hospital block, KMCT medical college, Mukkam, Kozhikode district, Pin 673602
Kozhikode
KERALA |
9846997377
drsoumyajose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCT MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Early term pregnant women with gestational age between 37 weeks and 38 weeks and 6 days |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betamethasone sodium phosphate |
12mg IM injection, Single dose given 24 hrs before caesarean section |
| Intervention |
Dexamethasone sodium phosphate |
6mg IM injection, 2 doses given 12 hours apart, so that second dose is recieved 24 hours before cesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mothers with age between 18 years and 45 years are selected and those satisfying the inclusion criteria are enrolled
Inclusion criteria
1 Early term babies (37+0 to 38+6 weeks)
2 Appropriate for gestational age (AGA) babies (It refers to a baby who is born with a weight between 10th and 90th percentile on the intergrowth 21 chart for gestational age and sex)
3 No antenatal risk factors for respiratory morbidity.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1 All preterm babies (<37 weeks)
2 All term babies (≥39 weeks)
3 All babies who have already received a course of antenatal steroids
4 All women who don’t have their gestational age confirmed via a first trimester’s dating scan
5 Multiple gestations
6 Risk factors like
Preeclampsia
Gestational diabetes mellitus (GDM) or pre-existing diabetes mellitus.
Maternal chorioamnionitis
Chronic hypertension, chronic renal disease, liver disease.
Prenatal ultrasonographic findings, such as oligohydramnios and structural lung disorders
Suspected intrauterine infections and fetus with major congenital anomalies or intrauterine growth restrictions
Meconium stained amniotic fluid (Grade I meconium stained liquor is translucent, light yellow green in colour, grade II MSL is opalescent with deep green and light yellow in colour, Grade III is opaque and deep green in colour)
Women who had hypersensitivities to dexamethasone/betamethasone or if the women came in labour prior to their scheduled elective CS date.
Perinatal asphyxia
7 General anesthesia and intraoperative maternal hypoxia
8 SGA and LGA babies
Small for gestational age (SGA) refers to a baby who is born with a weight below the 10th percentile on the intergrowth 21 chart for gestational age and sex.
Large for gestational age (LGA) refers to a baby who is born with a weight above the 90th percentile on the intergrowth 21 chart for gestational age and sex.
9 Mothers who have not given consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Any form of respiratory distress assessed in the form of APGAR score 7, Downes score 2 or more
|
Apgar scores at 1 and 5 min of life calculated.
oxygen saturation monitored at 5 and 10 min and general physical examination done. Downes score will be calculated.
Repeated assessment will be done at 2, 4,6, 12, 24 hours of life. Neonates are kept under observation for a total of 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes are severity of respiratory distress, hypoglycemia and level of care in response.
|
Neonates will be assessed at 0, 2, 4, 6, 12, 24, 48 hours of life. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/06/2023 |
| Date of Study Completion (India) |
01/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Caesarean delivery prior to onset of labor at term is a recognized risk factor for iatrogenic neonatal respiratory morbidities. There are multiple strategies to minimize the risk, and one of those is administration of antenatal corticosteroids. This is a comparative study to show Dexamethasone is equally efficacious as Betamethasone on preventing transient tachypnea of newborn after elective caesarean section in early term newborn. The study is intended to focus on the benefits of using dexamethasone as an alternative to betamethasone as it is easily available and cheaper. As of risk, low dose of steroids are expected to have very less chance of having long term harmful consequences to the infants born. Mothers satisfying the inclusion criteria are randomly divided by computer generated block randomization. They are divided into blocks of 4, 6. Based on this, half of participants will receive single dose of 12 mg betamethasone sodium phosphate intramuscular (IM) injection 24 hours before elective caesarean section. The another half will receive two doses 6 mg dexamethasone sodium phosphate intramuscular (IM) injection 12 hours apart, 24 hours before elective caesarean section. Caesarean sections will be performed under regional anesthesia (spinal) following the hospital protocol. Patients will be excluded if desaturation occurred intraoperatively (intraoperative maternal hypoxia) or if there is conversion to general anesthesia. Upon delivery, the babies will be attended immediately by the neonatal team in the operating theatre. The neonatal team will not be informed regarding the status of antenatal steroids until full assessment is completed. The details of the resuscitation will be documented. Neonatal assessments included Apgar scores at 1 and 5 min of life, oxygen saturation at 5 and 10 min, general physical examination and Downes score will be calculated. Neonates are kept under observation for 24 hours. Primary and secondary outcomes are measured. Ø The primary outcome is admission to NICU with TTN. Ø Secondary outcomes are severity of respiratory distress, hypoglycemia and level of care in response. And the outcomes of the results will be compared. |