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Trial record 99 of 179 for:    Phospholipids

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
Sponsor:
Collaborators:
Maulana Azad Medical College, New Delhi
Lady Hardinge Medical College
Chacha Nehru Bal Chikitsalya, Delhi
Postgraduate Institute of Medical Education and Research, Chandigarh
King Edward Memorial Hospital, Mumbai
Lokmanya Tilak Municipal General Hospital, Mumbai
Institute of Child health and Hospital for Children, Chennai
Jawaharlal Institute of Postgraduate Medical Education & Research
All India Institute of Medical Sciences, New Delhi
St Johns Medical College Hospital, Bangalore, India
King Edward Memorial Hospital, Pune
Government Medical College, Chandigarh
Wellcome Trust
Information provided by (Responsible Party):
Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi

Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Cadisurf Drug: Survanta Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Cadisurf (goat lung surfactant extract)
Neonates in the intervention group will be intratracheally administered 100 mg/kg of GLSE (CADISURF®).
Drug: 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) Drug: Survanta
Other Name: Beractant




Primary Outcome Measures :
  1. BPD free survival [ Time Frame: 36 weeks post menstrual age ]
    Survival free from BPD defined as per the definition provided by NIH


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)

  4. IVH grade 3 or 4 [ Time Frame: 72±24 hrs ]
    Grade 3 or 4 IVH as per Papille/Volpe classification

  5. Periventricular Leukomalacia (PVL)-cystic and non-cystic [ Time Frame: 72±24 hrs ]
    PVL as per deVries classification

  6. PVL-cystic and non-cystic [ Time Frame: 28±7days ]
    PVL as per deVries classification

  7. 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

  8. 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)

  9. 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)

  10. 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

  11. Neonatal Mortality [ Time Frame: first 28 days of life ]
    Death of a neonate in first 28 days of life

  12. Duration of mechanical ventilation and CPAP [ Time Frame: 36 weeks postmenstrual age ]
    Cumulative duration of mechanical ventilation and CPAP until discharge/death

  13. Duration of hospital stay [ Time Frame: 36 weeks postmenstrual age ]
    Duration of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates born at the study sites and fulfilling all of the following criteria will be eligible for enrolment in the study

    1. Gestational age ≤32 completed weeks
    2. Onset of respiratory distress within six hours of age
    3. If baby meets criteria for surfactant replacement therapy:

      1. FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or
      2. Baby needs intubation because of CPAP failure or severe respiratory distress (Chest X-ray is not mandatory for deciding the need for SRT). Detailed SOPs will be developed with respect to assessing the eligibility for SRT

        Exclusion Criteria:

        Neonates with any of the following criteria will be excluded:

    1. Gestation below 26 wk
    2. Babies with severe birth asphyxia as defined by the need for chest compressions and/or initial (umbilical arterial/or within 1 hour of birth) pH <7.0
    3. Major congenital malformations
    4. Prophylactic surfactant administration, i.e. administration of surfactant before the infant develops respiratory distress
    5. Air leak or pulmonary hemorrhage prior to enrollment
    6. Shock requiring vasopressor support prior to enrollment

Information from the National Library of Medicine

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


Contacts
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Contact: Ramesh Kumar Agarwal, DM (Neonatology) 0911-26596167 ra.aiims@gmail.com

Sponsors and Collaborators
Ramesh K Agarwal
Maulana Azad Medical College, New Delhi
Lady Hardinge Medical College
Chacha Nehru Bal Chikitsalya, Delhi
Postgraduate Institute of Medical Education and Research, Chandigarh
King Edward Memorial Hospital, Mumbai
Lokmanya Tilak Municipal General Hospital, Mumbai
Institute of Child health and Hospital for Children, Chennai
Jawaharlal Institute of Postgraduate Medical Education & Research
All India Institute of Medical Sciences, New Delhi
St Johns Medical College Hospital, Bangalore, India
King Edward Memorial Hospital, Pune
Government Medical College, Chandigarh
Wellcome Trust

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Responsible Party: Ramesh K Agarwal, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02774044     History of Changes
Other Study ID Numbers: N1617
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi:
preterm neonates, surfactant

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Beractant
Respiratory System Agents