Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates
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|ClinicalTrials.gov Identifier: NCT02774044|
Recruitment Status : Unknown
Verified May 2016 by Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Not yet recruiting
First Posted : May 17, 2016
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Drug: Cadisurf Drug: Survanta||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluating the Efficacy and Safety of an Innovative and Affordable Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates: a Multi-site Randomized Clinical Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Cadisurf (goat lung surfactant extract)
Neonates in the intervention group will be intratracheally administered 100 mg/kg of GLSE (CADISURF®).
Cadisurf Intratracheal suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural lung extract containing phospholipids and surfactant-associated proteins. The resulting composition provides 25 mg/mL phospholipids and less than 1.0 mg/ml protein. It is suspended in 0.9% sodium chloride solution. Cadisurf contains no preservatives. Each ml of Cadisurf contains 25 mg of phospholipids. It is a creamy white suspension supplied in single-use glass vials containing 8 mL (200 mg phospholipids).
Other Name: Goat lung surfactant extract
|Active Comparator: Survanta (Beractant)||
Other Name: Beractant
- BPD free survival [ Time Frame: 36 weeks post menstrual age ]Survival free from BPD defined as per the definition provided by NIH
- Area under the curve for (AUC) for oxygen requirement (FiO2) requirement in first 48 h [ Time Frame: 48 hours after surfactant replacement therapy ]The oxygen requirement will be recorded every hour using a standardized protocol and AUC for first 48 hrs will be calculated. The outcome would be recorded by the study staff and AUC calculated in a subset of 250 infants.
- Pulmonary haemorrhage [ Time Frame: 48 hours after surfactant replacement therapy ]Occurrence of bleeding/blood stained secretions from the trachea within 48 hr of surfactant administration
- Any air leak within 72 hours of administration of surfactant [ Time Frame: 72 hours after surfactant replacement therapy ]Occurrence of any airleak -pneumothorax, PIE or pneumomediastinum in chest X-ray (done when clinically suspected)
- IVH grade 3 or 4 [ Time Frame: 72±24 hrs ]Grade 3 or 4 IVH as per Papille/Volpe classification
- Periventricular Leukomalacia (PVL)-cystic and non-cystic [ Time Frame: 72±24 hrs ]PVL as per deVries classification
- PVL-cystic and non-cystic [ Time Frame: 28±7days ]PVL as per deVries classification
- Sepsis [ Time Frame: 7 days of age ]Occurrence of any episode of sepsis (culture positive or culture negative) from the time of enrolment until 7 days of age
- Respiratory support at 72 h [ Time Frame: 72 hours of age ]Mechanical ventilation/CPAP/HFNC/free flow oxygen/none at the two time points (point assessments)
- Respiratory support at 7 days of age [ Time Frame: 7 days of age ]Mechanical ventilation/CPAP/HFNC/free flow oxygen/none at the two time points (point assessments)
- Retinopathy of prematurity (ROP) [ Time Frame: Eyes of the babies would be examined by the ophthalmologists starting from 4 wk of life ]ROP requiring laser as per ICROP classification
- Neonatal Mortality [ Time Frame: first 28 days of life ]Death of a neonate in first 28 days of life
- Duration of mechanical ventilation and CPAP [ Time Frame: 36 weeks postmenstrual age ]Cumulative duration of mechanical ventilation and CPAP until discharge/death
- Duration of hospital stay [ Time Frame: 36 weeks postmenstrual age ]Duration of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774044
|Contact: Ramesh Kumar Agarwal, DM (Neonatology)||email@example.com|