Meconium Aspiration Syndrome, Surfactant Dysfunction
Conditions
Brief summary
The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.
Detailed description
Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life. Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol
Interventions
Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg
Sponsors
Lady Hardinge Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 2 Hours
Healthy volunteers
No
Inclusion criteria
* Gestation age ≥ 37 week * Cephalic presentation * Singleton pregnancy * Age \< 2 hours * Baby delivered through meconium stained amniotic fluid * Presence of respiratory distress (DOWNE's score ≥4)
Exclusion criteria
* Major congenital malformation * Antenatal diagnosed CHD * Hydrops fetalis * Air leaks before enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Total respiratory support | Birth to 28 days | Combined duration of invasive + non invasive ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of neonates requiring mechanical ventilation | Birth to 28 days | The babies will be assessed for the need for mechanical ventilation as per standard protocol |
| Proportion of neonates requiring Non Invasive Ventilation | Birth to 28 days | The babies will be assessed for the need for non invasive ventilation as per standard protocol |
| Duration of Mechanical Ventilation | Birth to 28 days | Total duration of Mechanical Ventilation in days |
| Severity of respiratory distress | Birth to 28 days | The severity of respiratory distress will be assessed using Downe's score. These parameters will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress |
| Complications | Birth to 28 days | Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks, |
| Mortality | Birth to 28 days | All cause mortality |
| Duration of hospital stay | Birth to 28 days | Total duration of hospital stay in days |
| Duration of oxygen therapy | Birth to 28 days | The duration of oxygen therapy, mode of delivery, Fio2 and flow rates will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress |
Countries
India
Outcome results
None listed