"Breathing in Newborns: Evaluating the Impact of Salbutamol, Furosemide, and Their Combination on Newborn Breathing at CMH Peshawar's Neonatal Intensive Care Unit"
"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"
Dr.Aamir Iqbal
200 participants
Aug 15, 2024
Interventional
Conditions
Summary
This study compares the effectiveness of salbutamol, furosemide, and their combination in treating transient tachypnea of the newborn (TTN) in the NICU. TTN is a common condition causing rapid breathing in newborns. We hypothesize that the combination of salbutamol and furosemide will be more effective than either drug alone. The primary outcomes are the time to symptom resolution and the duration of oxygen supplementation. This trial aims to identify the best treatment approach for improving recovery in newborns with TTN.
Eligibility
Inclusion Criteria9
- Age: Newborns (neonates) less than 48 hours old.
- 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.-
- Gestational Age: Full-term infants (37 to 42 weeks of gestation)
- Birth Weight: Appropriate for gestational age (AGA) infants with birth weight between 2.5 kg and 4.0 kg.
- 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.
Exclusion Criteria11
- Age:Newborns older than 48 hours.
- Diagnosis:-Presence of congenital heart disease or other significant congenital anomalies.
- Evidence of meconium aspiration syndrome or respiratory distress syndrome.
- Gestational Age:Preterm infants (less than 37 weeks of gestation) or post-term infants (more than 42 weeks of gestation).
- 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.
- 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).
- 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.
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Interventions
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.
Locations(1)
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ACTRN12624000987561