Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

Pulmonary Hypertension of Newborn Clinical Trial

— PaTTerN  

Official title:

Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide Via Invasive or Noninvasive Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03132428
• Other study ID #: MNK19050056
• Status: Terminated
• Start date: July 27, 2017
• Est. completion date: February 11, 2020

Study information

• Verified date: June 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through.

Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

1. Was either a P neonate born at least 27 weeks to less than 34 weeks of gestational age (GA) or a TNT neonate born at least 34 weeks but no more than 40 weeks of GA.

2. Was administered INOmax therapy after birth to 7 days of age via any route (invasive or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to 96 ± 12 hours. The participants may receive INOmax for a longer period.

3. Had PH, as confirmed by echocardiogram or a differential saturation gradient of at least 10%.

4. Received INOmax administration as part of routine clinical practice in a Level III or higher neonatal intensive care unit in the United States.

5. Has all variables required to calculate OI or SOI (a baseline sample prior to treatment and 4 samples obtained during treatment).

Exclusion Criteria:

1. Was at risk of imminent death (death expected within 24 hours).

2. Received extracorporeal membrane oxygenation (ECMO).

3. Had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal abnormality, congenital diaphragmatic hernia, congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).

4. Had been resuscitated requiring chest compressions within 6 hours of receiving INOmax.

5. Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.

6. Had active uncontrolled bleeding.

7. Had disseminated intravascular coagulopathy.

8. Had active seizures while receiving anticonvulsants.

9. Experienced prolonged asphyxia with evidence of severe acidosis (pH < 7.25).

10. Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from INOmax therapy.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension of Newborn

Intervention

Drug:
• INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation

Locations

Country	Name	City	State
United States	University of Chicago Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University Hospitals Rainbow Babies & Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of Iowa Stead Family Children's Hospital	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kentucky Chandler	Lexington	Kentucky
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	Loma Linda University Health Care	Loma Linda	California
United States	Miller Children's and Women's Hospital - Long Beach	Long Beach	California
United States	Norton Children's Hospital	Louisville	Kentucky
United States	University of Minnesota Amplatz Children's Hospital	Minneapolis	Minnesota
United States	Yale New Haven Children's Hospital	New Haven	Connecticut
United States	Children's Hospital of New Jersey at Newark Beth Israel Medical Center	Newark	New Jersey
United States	The Children's Hospital at OU Medical Center	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	Florida Hospital for Children	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Saint Louis Children's Hospital	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of neonates with significant response to INOmax treatment within each age group	Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment	within 108 hours
Secondary	Number of neonates with significant response to Inomax treatment within each age group and severity group	The severity of pulmonary hypertension (PH) is classified for each participant Categories: Mild, Moderate, Severe	within 108 hours
Secondary	Time to reach significant response to Inomax treatment within each age group and severity group	The median time to INOmax complete response (25% improvement) for neonates with each baseline PH severity classification Categories: Mild, Moderate, Severe	within 108 hours
Secondary	Number of neonates with partial response to INOmax treatment within each age group and severity group	Partial response is defined as less than a 25% improvement in OI/SOI during INOmax treatment	within 108 hours