None listed
Conditions
Brief summary
Introduction The neonatal mortality rate in Afghanistan is one of the highest in the world and it was reported by UNICEF in 2019, 37 deaths per 1000 live births. Prematurity is one of the major causes (35%) of early neonatal mortality in Afghanistan. Preterm and low birth weight neonates encounter a lot of serious problems including apnea. Although apnea is an important cause of mortality and brain damage in immature babies, the prophylactic effect of Caffeine on the apnea of prematurity in newborn infants is revealed by a few studies with conflicting results We Hypothesized that Caffeine citrate can prevent or decline the attacks of apnea in preterm neonates. Therefore we want to compare the prophylactic effects of Caffeine citrate versus placebo on the duration and daily attacks of apnea of prematurity in neonates with a gestational age of equal or less than 34 weeks or birth weight less than 1500g in Kabul hospitals. Research objectives: The primary objective is to compare the prophylactic effects of Caffeine citrate versus placebo on the duration and daily attacks of apnea of prematurity in neonates with a gestational age of equal or fewer than 34 weeks or birth weight less than 1500g in Kabul hospitals. The secondary objective is to evaluate the risk of neonatal death in both groups. Research Hypothesis: Caffeine citrate can prevent or decline the attacks of apnea in preterm neonates with a gestational age of equal or fewer than 34 weeks or birth weight less than 1500g in Kabul hospitals. Caffeine citrate has a prophylactic effect on apnea in such neonates group. Intervention: Totally,130 preterm neonates will be randomized to receive either Caffeine citrate (20mg/kg or 2ml/kg intravenously as the initial dose on the 1st day of life, and then 5 mg/kg or 0.5ml/kg intravenously daily as the maintenance dose for 10 days) or Placebo (distilled water 2ml/kg intravenously as the initial dose on the 1st day of life, and then(0.5ml/kg intravenously daily as the maintenance dose for 10 days) in this multisite, double-blind, controlled clinical trial.
Interventions
65 preterm neonates in group A will manage by Caffeine citrate 20 mg/kg (2ml/kg) intravenously as the initial dose on the 1st day, and then 5 mg/kg (0.5ml/kg) intravenously daily as the maintenance dose for 10 days. The Caffeine citrate solution will be prepared as 10mg/ml by a pharmacist and coded by a statistician before the intervention. This coded solution would be administrated by a trained nurse under the observation of a Neonatologist.
Sponsors
Mansoor Aslamzai
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Days to 7 Days
Healthy volunteers
No
Inclusion criteria
Neonates with the following criteria: 1. The gestational age of 34 weeks or less. 2. The birth weight less than 1500g.
Exclusion criteria
Neonates with the following conditions: 1. Neonatal Meningitis diagnosed by CSF and complete blood count. 2. Neonatal Pneumonia diagnosed by infiltration on chest x-ray and complete blood count. 3. Visible CNS malformation. 4. Cyanotic Congenital Heart Diseases detected by echocardiography. 5. Hypoxic-ischemic encephalopathy detected by Levene or Sarnat-Sartant Scoring System. 6. Severe perinatal asphyxia diagnosed as an Apgar score less than 4. 7. Hypoglycemia or blood glucose level less than 40mg/dl. 8. Hypocalcemia or blood calcium level less than 7.5mg/dl. 9. Severe Anemia defined as hemoglobin less than 10g/dl 10. Intraventricular hemorrhage detected by ultrasonography. 11. Hyponatremia or serum sodium level less than 135mq/l 12. Hypernatremia or serum sodium level more than 145mq/l 13. Parents who declined the consents.
Outcome results
None listed