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Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757782
First Posted: December 31, 2012
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital
  Purpose
The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns and to study risk factors of MAS developing into PPHN.

Condition Intervention Phase
Meconium Aspiration Syndrome Persistent Pulmonary Hypertension of Newborn Drug: Oral Sildenafil Drug: Placebo (distilled water) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns: A Randomized Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Hypertension
Drug Information available for: Sildenafil Sildenafil citrate
Genetic and Rare Diseases Information Center resources: Meconium Aspiration Syndrome
U.S. FDA Resources

Further study details as provided by Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital:

Primary Outcome Measures:
  • Improvement in oxygen saturation (SpO2) [ Time Frame: 26 hours, 50 hours ]
    Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)


Secondary Outcome Measures:
  • Oxygenation index [ Time Frame: 26 hours, 50 hours ]
    Oxygenation index of neonates kept on ventilator 2 hours after dose of oral sildenafil (24 hours and 48 hours) [Oxygenation index (OI) = Mean airway pressure (cm H2O) × FiO2 × 100/ PaO2 [fraction of inspired oxygen- FiO2] [Arterial partial pressure of oxygen- PaO2]


Other Outcome Measures:
  • Mortality of patients enrolled in study [ Time Frame: Upto 4 weeks ]
    During time of hospital stay(upto 4 weeks).
Enrollment: 96
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Sildenafil
In group A, newborns received oral Sildenafil solution through feeding tube which was prepared by crushing a 50 mg tablet of sildenafil in distilled water to make a concentration of 5 mg/ml. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses.
 Drug: Oral Sildenafil
Patients were randomized into two groups. Placebo was prepared with distilled water. In group A, newborns received oral Sildenafil solution through feeding tube which was prepared by crushing a 50 mg tablet of sildenafil in distilled water to make a concentration of 5 mg/ml. In group B, newborns received placebo. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses, (3) Dose was doubled if the oxygenation index (OI) or SpO2 did not improve (If OI continued to be <10% of previous value and SpO2 was not increasing >5 of previous value) and blood pressure remained stable
Other Names:
  • Viagra
  • Integra
Placebo Comparator: Distilled water
In group B, newborns received placebo. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses.
 Drug: Placebo (distilled water)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns were diagnosed with MAS if any of the two of the following three criteria were present. (1) Meconium staining of liquor or staining of umbilical cord or skin or nails. (2) Respiratory distress, within one hour of birth. (3) Radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation). Newborns with MAS diagnosed with clinical PPHN were enrolled in the study for drug trial. PPHN was determined either clinically by loud P2(second component of second heart sound), 10% or greater pre-/post ductal difference in arterial oxygenation (obtained by acid base gas analysis) or upper limb- lower limb SpO2 difference (obtained by pulse oximetry).

Exclusion Criteria:

  • (a) babies with congenital heart disease (b) congenital anomalies particularly those which were incompatible to life or which was the cause for respiratory distress e.g. diaphragmatic hernia (c) Respiratory morbidities such as hyaline membrane disease, congenital pneumonia (d) Babies with PPHN secondary to MAS admitted after 12 hours of delivery (e) Non availability of consent of guardian for interventional procedures
  Contacts and Locations
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): NCT01757782


Locations
India
Pediatrics department
Bhavnagar, Gujarat, India, 364002
Sponsors and Collaborators
Sir Takhtasinhji General Hospital
Investigators
Principal Investigator: Jayendra R Gohil, MD Professor of Pediatrics, Dept of Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
  More Information

Publications:
Vargas-Origel A, Gómez-Rodríguez G, Aldana-Valenzuela C, Vela-Huerta MM, Alarcón-Santos SB, Amador-Licona N. The use of sildenafil in persistent pulmonary hypertension of the newborn. Am J Perinatol. 2010 Mar;27(3):225-30. doi: 10.1055/s-0029-1239496. Epub 2009 Oct 28.

Responsible Party: Jayendra R. Gohil, MD, PROF., Professor in Pediatrics, Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier: NCT01757782     History of Changes
Other Study ID Numbers: Sildenafil
First Submitted: December 18, 2012
First Posted: December 31, 2012
Last Update Posted: June 26, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Syndrome
Hypertension
Hypertension, Pulmonary
Meconium Aspiration Syndrome
Persistent Fetal Circulation Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Injury
 Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents


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