Can Caffeine prevent the cessation of breathing in preterm newborn babies?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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. CONDITION: Prematurity;Apnea of Prematurity;Low Birth Weight; ; Prematurity ; Apnea of Prematurity ; Low Birth Weight Reproductive Health and Childbirth ‐ Complications of newborn Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: The frequency of apnea attacks in 24hr[The neonates will be observed for 10days and the mean number of apnea in 24hrs would be obtained. The number of apnea in 24hrs will be monitored and assessed by an Apnea Monitor and a recording sheet. ] The risk of apnea is defined as a cessation of breathing for 20 seconds or longer or a shorter pause accompanied by bradycardia (heart rate less than 100 beats per minute), cyanosis, or low blood oxygen saturation. The apnea will be diagnosed and assessed by Cardio‐respiratory Monitor.[10days. The risk of apnea would be calculated from the number of preterm neonates with newly diagnosed apnea during 10days of intervention divided by the number of totals studied preterm neonates on this date.] The total duration of apnea attacks will be demonstrated in days. The duration of apnea attacks will be calculated from the starting day up to the ending day of apnea. The apnea would be assessed and diagnosed by Apnea Monitor or Cardio‐pulmonary Monitor.[The duration of apnea attacks will be calculated from the starting day up to the ending day of apnea. The observation period is 10days. The assessment and diagnosis of apnea would be done by Apnea Monitor or Cardio‐pulmonary Monitor. ] SECONDARY OUTCOME: The risk of neonatal death during the intervention.[10 days. The risk of neonatal death would be calculated from the number of dead preterm neonates during 10days of intervention divided by the number of totals studied preterm neonates on this date.] INCLUSION CRITERIA: Neonates with the following criteria: 1. The gestational age of 34 weeks or less. 2. The birth weight less than 1500g.
Epistemonikos ID: ec6528d01a81dc3c2e2af3c32cea43c6d9b5b68c
First added on: Aug 25, 2024