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

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ClinicalTrials.gov Identifier: NCT01757782

Recruitment Status : Completed

First Posted : December 31, 2012

Last Update Posted : June 26, 2014

Sponsor:

Information provided by (Responsible Party):

Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital

Study Description

Brief Summary:

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	96 participants
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
Study Start Date :	December 2011
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	September 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm	Intervention/treatment
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)

Arm

Intervention/treatment

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)

Outcome Measures

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).

Eligibility Criteria

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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 Posted:	December 31, 2012 Key Record Dates
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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