comparison of two types of ventilation modes given through ventilator after treating with surfactant (medicine)needed to breath easily in premature infants
- Conditions
- Neonatal Respiratory Distress Syndrome
- Registration Number
- CTRI/2018/01/011116
- Lead Sponsor
- Kasturba Hospital
- Brief Summary
This is a prospective observational study involving collection of data of standard of care therapy [non-invasive ventilation(NCPAP, NIPPV)] and does not involve any additional intervention. As studies done on comparison between these two modes of non-invasive ventilation within MIST are limited in India, it has been taken as thesis topic.
Study period : 1 year (May2017- April 2018)
Sample size : 40 infants in each group
Statistical methods : Previous data suggests that 40% of the preterm infants who receive early CPAP and rescue surfactant for RDS needed invasive ventilation within first 72h of life. Predicting a 20% absolute reduction in the need for invasive ventilation with MIST. For a power of 80%, with two- sided significance level of an α error rate of 5%, we calculated sample size of 40 infants in each group.
Continuous variables will be presented as median using- independent sample t- test, independent groups using Mann- Whitney U test and Categorical variables using χ2 test ,presented as number and percentage. In addition to p value of the primary outcome, results will be given as differences and 95% confidence intervals. A p value <0.05 was considered statistically significant.
Neonate details like date of birth, admission, gestational age, birth weight, gender, Apgar score, prenatal steroid administration, mode of delivery, basic vitals on admission are to be recorded. Downe’s score for respiratory distress will be assessed every 4 hours for the first 48 hours.
Each infant will be assigned NCPAP or NIPPV according to concerned neonatologist’s opinion and will be started within 30 min of birth.
Both NCPAP and NIPPV will be delivered by neonatal ventilator (Drager Babylog 8000) via nasal mask. NCPAP pressure will be set at 5–6 cm H2O, and NIPPV will be set in a non-synchronised mode at 20–30 bpm, with PEEP of 5–6 cm H2O and PIP of 15–20 cm H2O. FiO2 will be titrated at 0.21–0.50 to maintain an oxygen saturation level of 90%–95%, as measured via pulse oximeter.
Under non-invasive ventilation surfactant will be administered as a rescue therapy if the infant requires FiO2 > 0.4 to maintain the target saturation level of 90-95%.A dose of 4ml/kg (100mg /kg of phospholipid) Survanta® (beractant)] or 2.5ml/kg (200mg/kg of phospholipid) Curosurf®, Chiesi Farmaceitici S.p.A, Parma, Italy] of surfactant will be administered within the MIST approach via a gastric tube placed in the trachea in patients who met the criteria for surfactant administration
Pulse oximeter saturation, heart rate and respiratory rate and blood pressure will be monitored continuously by the Philips IntelliVue Patient Monitor MP20 monitor.There will be a continuous monitoring of the number of days requiring respiratory support till the neonate is off oxygen support.There will be no additional intervention involved in this observational studyInfants who failed under NCPAP/NIPPV and required surfactant therapy will be administrated surfactant via the endotracheal tube if necessary, as they will be already intubated. The initial mode of nasal support (NIPPV or NCPAP) will be continued until the patient is weaned from it in accordance with our NICU practice. Infants supported with NCPAP will not allowed to be switched to NIPPV when the severity of their respiratory symptoms increased. Infants intubated in the first 72 h of life will be extubated to their allocated mode.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
will be selecting babies born at 28-32 weeks of gestation, presented with signs of respiratory distress (Tachypnea, flaring of nostrils, grunt and retractions).
- 1.Neonates requiring intubation in the delivery room.
- 2.Neonates with major congenital malformations.
- 3.Out born neonates.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Need for intubation and mechanical ventilation within the first 72 hours of life. 1.Need for intubation and mechanical ventilation within the first 72 hours of life.
- Secondary Outcome Measures
Name Time Method 1.Duration of non- invasive ventilation. 2.Duration of invasive ventilation.
Trial Locations
- Locations (1)
Neonatal Intensive Care Unit
🇮🇳Udupi, KARNATAKA, India
Neonatal Intensive Care Unit🇮🇳Udupi, KARNATAKA, IndiaMrudula M SawadkarPrincipal investigator8975744517mrudula.sawadkar@gmail.com