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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early bolus surfactant replacement therapy | Experimental | Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life |
|
| Standard care | No Intervention | Neonates randomized to this group will be managed as per standard protocol in the neonatal unit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bovine surfactant | Drug | Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Total respiratory support | Combined duration of invasive + non invasive ventilation | Birth to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of respiratory distress | 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 | Birth to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sushma Nangia, MD, DM (Neo) | Lady Hardinge Medical College, New Delhi, India | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Hardinge Medical College | New Delhi | National Capital Territory of Delhi | 110001 | India |
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| ID | Term |
|---|---|
| D008471 | Meconium Aspiration Syndrome |
| C580477 | Surfactant Dysfunction |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Proportion of neonates requiring mechanical ventilation |
The babies will be assessed for the need for mechanical ventilation as per standard protocol |
| Birth to 28 days |
| Proportion of neonates requiring Non Invasive Ventilation | The babies will be assessed for the need for non invasive ventilation as per standard protocol | Birth to 28 days |
| Duration of Mechanical Ventilation | Total duration of Mechanical Ventilation in days | Birth to 28 days |
| Duration of oxygen therapy | 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 | Birth to 28 days |
| Complications | Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks, | Birth to 28 days |
| Mortality | All cause mortality | Birth to 28 days |
| Duration of hospital stay | Total duration of hospital stay in days | Birth to 28 days |
| D005315 |
| Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |