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Completed

NCT Number: NCT01801982

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

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.

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Key information

Conditions

Pulmonary Hypertension, Persistent, of the Newborn Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

0 year–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Ormond Street Hospital, Paediatric Intensive Care

London, WC1N 3JH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. Number of Participants With Physical Examination Abnormalities at Month 12

    Time frame: Month 12

    Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.

  2. Number of Participants With Physical Examination Abnormalities at Month 24

    Time frame: Month 24

    Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.

  3. Number of Participants With Clinically Significant Medical History at Month 12

    Time frame: Month 12

    Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.

  4. Number of Participants With Clinically Significant Medical History at Month 24

    Time frame: Month 24

    Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.

Secondary outcomes

  1. Overall Survival at Month 12

    Time frame: Month 12

    Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.

  2. Overall Survival at Month 24

    Time frame: Month 24

    Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.

  3. Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: Up to Month 12

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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