Caffeine to decrease the oxygen support duration in moderate and late preterm a randomised control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Total duration of oxygen therapy
Study Overview
Brief Summary
AIMS AND OBJECTIVES
PRIMARY OUTCOME
Total duration of oxygen therapy
SECONDARY OUTCOMES
Hs PDA Requiring Treatment
Feed Intolerance Requiring >12 Hrs Of Interruption Of Feed.
Frequency Of Intermittent Hypoxia Before Discharge between two groups
Anthropometry
Prevalence of Retinopathy Of Prematurity, Bronchopulmonary Dysplasia, other respiratory Morbidity prior to discharge (Pneumothorax, PPHN, Requirement Of Surfactant)
MATERIALS AND METHODS
TITLE- caffeine to decrease oxygen support duration in moderate and late preterm- a randomized control trial
TYPE OF STUDY- Randomized Controlled Trial
STUDY AREA- Neonatal Intensive Care Unit, Neotia Getwel Multispeciality Hospital
STUDY PERIOD – 1 Year
STUDY POPULATION- all the neonates between 32 -36+6 weeks getting admitted in NICU between the study period
INCLUSION CRITERIA
- PMA: 320/7-36 6/7 weeks & PNA <14 days
- Requiring respiratory support (NPO2,NCPAP,HHHFNC,NIV) for >6 hours post birth.
EXCLUSION CRITERIA
- Major congenital abnormality
- Renal or hepatic failure
- Arrythmias
- Babies requiring invasive MV within < 6 hrs
- Caffeine received previously within 48 hours
METHODOLOGY:
Baby parents were counselled about the study and it’s purpose. Proper consent has to be taken.
total number of patients will be divided (after all inclusion and exclusion criterias are met) into group ‘A’ and ‘B’.
Group ’A’ will be given 20 mg/kg (as loading dose) caffeine citrate followed by 10mg/kg (as maintainance dose) till baby comes out of O2 support.
Group’B’ will be given standard care and caffeine citrate to be considered only when they develop apnea of prematurity or baby requires invasive ventilation.
Both group’A’ and group’B’ babies will be monitored on the basis of following parameters and will be followed up till 44 wks PMA
1.Intermittent hypoxia Episodes per 24 Hrs.
2.Duration Of Oxygen Support.
3.Any Complication Of Respiratory Support (Pneumothorax, Shock).
4.Side Effect Of Caffeine Therapy.
5.Feed Intolerance.
6.Interruption Of Feeding For 12 Hours.
7.Gestation Age For Discharge (Off Respiratory Support >48hrs, Gaining Weight Adequately, taking full feed by KS/ bottle, Mother Confident, No Major Morbidity).
8.Prevalance Of Re hospitalization before 44 Week Post Menstrual Age (PMA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Day(s) to 14.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •PMA: 320/7-36 6/7 weeks & PNA less than 14 days Requiring respiratory support (NPO2,NCPAP,HHHFNC,NIV) for more than 6 hours post birth.
Exclusion Criteria
- •Major congenital abnormality Renal or hepatic failure Arrythmias Babies requiring invasive MV within 6 hrs Caffeine received previously within 48 hours.
Outcomes
Primary Outcomes
Total duration of oxygen therapy
Time Frame: at baseline,1 wk & 2 wk and at discharge
Secondary Outcomes
- Hs PDA Requiring Treatment(any time prior to discharge)
- Feed Intolerance Requiring more than 12 Hrs Of Interruption Of Feed.
- Frequency Of Intermittent Hypoxia(at 1 wk& 2 wk &3 wk and at discharge)
- Prevalence of Retinopathy Of Prematurity, Bronchopulmonary Dysplasia, other respiratory Morbidity prior to discharge(any time prior to discharge)
- Anthropometry.
Investigators
Dr Aritra Ray
Neotia Getwel Healthcare Centre