A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01801982
First received: January 8, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.


Condition Intervention
Pulmonary Hypertension, Persistent, of the Newborn
Other: non-interventional

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Developmental progress

  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Developmental progress

  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Hearing test to be conducted by HCP

  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Hearing test to be conducted by HCP


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
    safety

  • Overall Survival (OS) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    safety


Enrollment: 1
Study Start Date: November 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: non-interventional
    non-interventional
Detailed Description:

This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.

  Eligibility

Ages Eligible for Study:   10 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil

Criteria

Inclusion Criteria:

  • Any subject who received sildenafil treatment in study A1481276.
  • Signed and dated informed consent document by legal guardian.

Exclusion Criteria:

  • Any subject who did not receive sildenafil treatment during study A1481276.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801982

Locations
United Kingdom
Great Ormond Street Hospital, Paediatric Intensive Care
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01801982     History of Changes
Other Study ID Numbers: A1481283
Study First Received: January 8, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PPHN; development progress after PPHN; developmental progress after sildenafil.

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014