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Trial registered on ANZCTR


Registration number
ACTRN12624000987561
Ethics application status
Approved
Date submitted
29/06/2024
Date registered
13/08/2024
Date last updated
13/08/2024
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
"Breathing in Newborns: Evaluating the Impact of Salbutamol, Furosemide, and Their Combination on Newborn Breathing at CMH Peshawar's Neonatal Intensive Care Unit"
Scientific title
"Evaluating the Comparative Efficacy of Salbutamol, Furosemide, and Their Combination for Treating Transient Tachypnea of the Newborn (TTN) at CMH Peshawar's Neonatal Intensive Care Unit"
Secondary ID [1] 312280 0
'None'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient Tachypnea of the Newborn 334018 0
Condition category
Condition code
Respiratory 330688 330688 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 331067 331067 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Name:
Efficacy of Salbutamol, Furosemide, and Their Combination in Treating Transient Tachypnea of the Newborn (TTN)
Intervention Arms:
Arm 1: Salbutamol Therapy
- Intervention: Single dose of nebulized salbutamol.
- Dosage: 0.15 mg/kg.
- Administration: Administered using a nebulizer to deliver the medication directly to the lungs.
- Procedure: Salbutamol will be prepared according to the specified dose and nebulized for inhalation by the neonate.
Arm 2: Furosemide Therapy
- Intervention: Single dose of intravenous furosemide.
- Dosage: 1 mg/kg.
- Administration: Administered via intravenous injection.
- Procedure: Furosemide will be dosed based on the neonate's weight and administered IV over a short period.
Arm 3: Combination Therapy
- Intervention: Administration of both nebulized salbutamol and intravenous furosemide at the specified doses.
- Dosage:
- Nebulized Salbutamol: 0.15 mg/kg.
- Intravenous Furosemide: 1 mg/kg.
- Administration: Nebulized salbutamol will be given first, followed by intravenous furosemide.
- Procedure: Each drug will be prepared and administered as per the protocols described for the individual arms.
Common Details for All Arms:
Who Provides the Interventions:
- The interventions will be administered by trained NICU nurses with expertise in neonatal care, ensuring safety and accuracy in dosing and delivery.
Location:
- The study will be conducted in the Neonatal Intensive Care Unit (NICU) at Combined Military Hospital (CMH) Peshawar, which is equipped with the necessary infrastructure and facilities for high-quality neonatal care.
Procedure:
- Each intervention will be given as a single dose. The neonates will be closely monitored before, during, and after administration for any adverse effects and for assessing the clinical response.
Monitoring and Safety:
- Continuous monitoring of vital signs (heart rate, respiratory rate, oxygen saturation) will be conducted to ensure the safety and well-being of the neonates.
- Any adverse events will be recorded and managed according to standard clinical protocols.
Adherence Monitoring Strategies:
Adherence to the intervention will be monitored through the review of hospital medical records and direct observation by clinical staff to ensure correct administration and adherence to the intervention protocols.
Protocol for Adverse Events:
In case of any adverse event, participants will be immediately reviewed by the treating clinician. Appropriate measures will be taken, including discontinuation of the intervention if necessary, and the neonates will be provided with the most suitable alternative treatment available based on standard clinical practice.
Intervention code [1] 328836 0
Treatment: Drugs
Comparator / control treatment
Control Treatment: Placebo
Intervention:
Administration of placebo to serve as the control treatment in the study.
Dosage:
Nebulized Placebo: An equivalent volume of sterile saline solution matching the volume used for nebulized salbutamol.

Intravenous Placebo: An equivalent volume of sterile water matching the volume used for intravenous furosemide.
Administration:
Nebulized Placebo: Administered using a nebulizer in the same manner as nebulized salbutamol.
Intravenous Placebo: Administered via intravenous injection in the same manner as intravenous furosemide.
Procedure:
For the nebulized placebo, the sterile saline solution will be prepared and administered using the same nebulizer setup and procedures as for salbutamol.
For the IV placebo, the sterile water will be prepared and administered using the same IV setup and procedures as for furosemide.
Who Provides the Control Treatment:
The placebo will be administered by trained NICU nurses with expertise in neonatal care, ensuring consistency and precision in delivery.
Location:
The control treatment will be administered in the Neonatal Intensive Care Unit (NICU) at Combined Military Hospital (CMH) Peshawar, ensuring that the environment and conditions are the same for all study groups.
Monitoring and Safety:
Continuous monitoring of vital signs (heart rate, respiratory rate, oxygen saturation) before, during, and after administration of the placebo to ensure the safety of the neonates.Any adverse events will be recorded and managed according to standard clinical protocols, ensuring prompt response to any potential issues.
Reference Comparator:
The placebo group (both nebulized saline solution and intravenous sterile water) is considered the reference comparator for this study.
Control group
Placebo

Outcomes
Primary outcome [1] 338555 0
Primary Outcome:
Outcome Name:
Time to resolution of transient tachypnea of the newborn (TTN) symptoms
Description:
Composite primary outcome assessing the resolution of TTN symptoms, including:
.Respiratory rate normalization
Oxygen saturation stabilization
Measurement:
Time (in hours) from the initiation of treatment to the resolution of all specified TTN symptoms
Timepoint [1] 338555 0
Primary Timepoint:
Timepoint Relative to Intervention: Daily assessments starting from the initiation of treatment.
Maximum Follow-Up Duration:
Assessments will continue until the resolution of TTN symptoms or up to 7 days from the initiation of treatment, whichever comes first.
Definition of Primary Timepoint: The primary timepoint is defined as the time when respiratory rates and oxygen saturation levels are normalized and sustained without the need for supplemental oxygen.
Primary outcome [2] 338556 0
Duration of supplemental oxygen therapy
Timepoint [2] 338556 0
Primary Timepoint:
Timepoint Relative to Intervention: From the initiation of supplemental oxygen therapy.
Maximum Follow-Up Duration: Until the newborn no longer requires supplemental oxygen therapy.
Specific Recording Details: Daily recordings of the duration of supplemental oxygen therapy will be made until the newborn can maintain normal oxygen saturation levels without supplemental oxygen.
Secondary outcome [1] 436435 0
"Hospital length of stay "
Timepoint [1] 436435 0
Assessed at discharge.
Secondary outcome [2] 436436 0
"Incidence of adverse effects"
Timepoint [2] 436436 0
Secondary Timepoint:
Timepoint Relative to Intervention: From the initiation of the intervention (e.g., start of treatment) and continuously throughout the intervention period.
Maximum Follow-Up Duration: Documented daily until discharge from the NICU.

Eligibility
Key inclusion criteria
1.Age: Newborns (neonates) less than 48 hours old.
2.Diagnosis: Confirmed diagnosis of transient tachypnea of the newborn (TTN) based on clinical and radiological findings, including:-
-Clinical Findings: Rapid breathing (respiratory rate > 60 breaths per minute), grunting, nasal flaring, and mild to moderate retractions.-
-Radiological Findings: Chest X-ray showing prominent pulmonary vascular markings, fluid in the fissures, and/or mild overexpansion.-
3.Gestational Age: Full-term infants (37 to 42 weeks of gestation)
4.Birth Weight: Appropriate for gestational age (AGA) infants with birth weight between 2.5 kg and 4.0 kg.
5.Vital Signs: Stable cardiovascular status, defined by:
-Heart Rate: 100 to 160 beats per minute
-Blood Pressure: Systolic 60-90 mmHg, Diastolic 30-60 mmHg 6.Consent: Written informed consent obtained from parents or legal guardians.
Minimum age
2 Hours
Maximum age
48 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Age:Newborns older than 48 hours.
2.Diagnosis:-Presence of congenital heart disease or other significant congenital anomalies.
-Evidence of meconium aspiration syndrome or respiratory distress syndrome.
3.Gestational Age:Preterm infants (less than 37 weeks of gestation) or post-term infants (more than 42 weeks of gestation).
4.Birth Weight:Small for gestational age (SGA) infants with birth weight below 2.5 kg or large for gestational age (LGA) infants with birth weight above 4.0 kg.
5.Vital Signs:Unstable cardiovascular status, defined by abnormal heart rate or blood pressure for age despite medical management.
-Abnormal heart rate (< 100 beats per minute or > 160 beats per minute).
-Abnormal blood pressure (Systolic < 60 mmHg or > 90 mmHg, Diastolic < 30 mmHg or > 60 mmHg).
6.Medical History:
-History of maternal drug use during pregnancy known to affect respiratory function (e.g., beta-blockers, narcotics).
-History of birth asphyxia or perinatal hypoxia.Informed 7.Consent:Lack of written informed consent from parents or legal guardians.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation was concealed using sealed opaque envelopes."
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
"Simple randomisation using procedures like coin-tossing and dice-rolling"
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2024
Actual
Date of last participant enrolment
Anticipated
25/10/2024
Actual
Date of last data collection
Anticipated
20/11/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 26381 0
Pakistan
State/province [1] 26381 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 316669 0
Hospital
Name [1] 316669 0
Combined Military Hospital, Peshawar
Country [1] 316669 0
Pakistan
Primary sponsor type
Individual
Name
Dr.Aamir Iqbal
Address
Country
Pakistan
Secondary sponsor category [1] 318854 0
Individual
Name [1] 318854 0
Dr. Shakeel Ahmed
Address [1] 318854 0
Country [1] 318854 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315447 0
Ethical Review Committee for Medical and Biomedical Research CMH Peshawar
Ethics committee address [1] 315447 0
Ethics committee country [1] 315447 0
Pakistan
Date submitted for ethics approval [1] 315447 0
17/07/2024
Approval date [1] 315447 0
23/07/2024
Ethics approval number [1] 315447 0
00293/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134730 0
Dr Aamir Iqbal
Address 134730 0
Combined Military Hospital, Cantonment Board Peshawar, Postal Code#25000, Khyber Pakhtunkhwa
Country 134730 0
Pakistan
Phone 134730 0
+923312396289
Fax 134730 0
Email 134730 0
[email protected]
Contact person for public queries
Name 134731 0
Aamir Iqbal
Address 134731 0
Combined Military Hospital, Cantonment Board Peshawar, Postal Code#25000, Khyber Pakhtunkhwa
Country 134731 0
Pakistan
Phone 134731 0
+923312396289
Fax 134731 0
Email 134731 0
[email protected]
Contact person for scientific queries
Name 134732 0
Aamir Iqbal
Address 134732 0
Combined Military Hospital, Cantonment Board Peshawar, Postal Code#25000, Khyber Pakhtunkhwa
Country 134732 0
Pakistan
Phone 134732 0
+923312396289
Fax 134732 0
Email 134732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
"All individual participant data collected during the trial, after de-identification, will be shared. This includes data underlying the published results such as demographics, clinical characteristics, treatment outcomes, and adverse events."
When will data be available (start and end dates)?
"Data will be available beginning 3 months following the publication of the main results and ending 5 years after publication."
Available to whom?
Only researchers who provide a methodologically sound proposal will be able to access the data
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal, including individual participant data (IPD) meta-analyses."
How or where can data be obtained?
Access to the data will be subject to approval by the Principal Investigator. Interested researchers should contact [[email protected]] for further information and to submit their proposals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23921Ethical approval  [email protected]
23922Informed consent form  [email protected]
23923Clinical study report  [email protected]
23924Data dictionary  [email protected]
23925Study protocol  [email protected]
23926Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.