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: April 11, 2014
Last verified: April 2014

January 8, 2013
April 11, 2014
November 2012
January 2014   (final data collection date for primary outcome measure)
  • 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
  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01801982 on ClinicalTrials.gov Archive Site
  • 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
  • Overall Survival (OS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Overall Survival (OS) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Pulmonary Hypertension, Persistent, of the Newborn
Other: non-interventional
non-interventional
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
10 Months to 14 Months
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01801982
A1481283
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP