Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates

NCT02774044 | Unknown Phase 2 DMC

• 1 other identifier: N1617
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Respiratory Distress Syndrome

Keywords

preterm neonates, surfactant

Outcome Measures

Primary Outcomes (1)

• BPD free survival

  Survival free from BPD defined as per the definition provided by NIH

  36 weeks post menstrual age

Secondary Outcomes (13)

• Area under the curve for (AUC) for oxygen requirement (FiO2) requirement in first 48 h

  48 hours after surfactant replacement therapy

• Pulmonary haemorrhage

  48 hours after surfactant replacement therapy

• Any air leak within 72 hours of administration of surfactant

  72 hours after surfactant replacement therapy

• IVH grade 3 or 4

  72±24 hrs

• Periventricular Leukomalacia (PVL)-cystic and non-cystic

  72±24 hrs

Study Arms (2)

Cadisurf (goat lung surfactant extract)

EXPERIMENTAL

Neonates in the intervention group will be intratracheally administered 100 mg/kg of GLSE (CADISURF®).

Drug: Cadisurf

Survanta (Beractant)

ACTIVE COMPARATOR

Drug: Survanta

Interventions

Cadisurf DRUG

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).

Also known as: Goat lung surfactant extract

Cadisurf (goat lung surfactant extract)

Survanta DRUG

Also known as: Beractant

Survanta (Beractant)

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates born at the study sites and fulfilling all of the following criteria will be eligible for enrolment in the study
• Gestational age ≤32 completed weeks
• Onset of respiratory distress within six hours of age
• If baby meets criteria for surfactant replacement therapy:
• FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or
• 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

You may not qualify if:

• Neonates with any of the following criteria will be excluded:
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• Gestation below 26 wk
• 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
• Major congenital malformations
• Prophylactic surfactant administration, i.e. administration of surfactant before the infant develops respiratory distress
• Air leak or pulmonary hemorrhage prior to enrollment
• Shock requiring vasopressor support prior to enrollment

Sponsors & Collaborators

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

Related Publications (1)

• Jain K, Nangia S, Ballambattu VB, Sundaram V, Sankar MJ, Ramji S, Vishnubhatla S, Thukral A, Gupta YK, Plakkal N, Sundaram M, Jajoo M, Kumar P, Jayaraman K, Jain A, Saili A, Murugesan A, Chawla D, Murki S, Nanavati R, Rao S, Vaidya U, Mehta A, Arora K, Mondkar J, Arya S, Bahl M, Utture A, Manerkar S, Bhat SR, Parikh T, Kumar M, Bajpai A, Sivanandan S, Dhawan PK, Vishwakarma G, Bangera S, Kumar S, Gopalakrishnan S, Jindal A, Natarajan CK, Saini A, Karunanidhi S, Malik M, Narang P, Kaur G, Yadav CP, Deorari A, Paul VK, Agarwal R. Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial. J Perinatol. 2019 Sep;39(Suppl 1):3-12. doi: 10.1038/s41372-019-0472-0.

  PMID: 31485014 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

goat lung surfactant extract; beractant

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Ramesh Kumar Agarwal, DM (Neonatology)

CONTACT

0911-26596167; ra.aiims@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 17, 2016

Record last verified: 2016-05