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

NCT ID: NCT01801982

Last Updated: 2021-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension, Persistent, of the Newborn

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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non-interventional

non-interventional

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Great Ormond Street Hospital, Paediatric Intensive Care

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

Other Identifiers

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2010-021266-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A1481283

Identifier Type: -

Identifier Source: org_study_id

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