The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nebulized nitroglycerine as adjunctive therapy

conventional therapy for PPHN

About this trial

This is an interventional treatment trial for Persistent Pulmonary Hypertension of the Newborn

Eligibility Criteria

1 Hour - 7 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial. Exclusion Criteria: • Diagnosis of PPHN discovered after more than 72 hours. Failure of used medications and need to administrate milrinone

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I (nebulized nitroglycerine)

Group II (conentional treatment group)

Arm Description

Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN

Patients with PPHN and will be treated with conventional regimen for PPHN

Outcomes

Primary Outcome Measures

Estimation of Pulmonary artery pressure (PAP)

Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation. The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope. Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed.

Right ventricular (RV) function in ml/kg/min

• RV output and stroke distance in main pulmonary artery: CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR.

Left ventricular (LV)function in ml/kg/min

LV output and stroke distance in ascending aorta: CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view). SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR.

Secondary Outcome Measures

Full Information

NCT ID

NCT05741229

First Posted

February 14, 2023

Last Updated

May 11, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05741229

Brief Title

The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns

Official Title

The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 20, 2023 (Anticipated)

Primary Completion Date

December 20, 2023 (Anticipated)

Study Completion Date

January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I (nebulized nitroglycerine)

Arm Type

Active Comparator

Arm Description

Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN

Arm Title

Group II (conentional treatment group)

Arm Type

Placebo Comparator

Arm Description

Patients with PPHN and will be treated with conventional regimen for PPHN

Intervention Type

Drug

Intervention Name(s)

Nebulized nitroglycerine as adjunctive therapy

Intervention Description

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

Intervention Type

Drug

Intervention Name(s)

conventional therapy for PPHN

Intervention Description

patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation.

Primary Outcome Measure Information:

Title

Estimation of Pulmonary artery pressure (PAP)

Description

Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation. The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope. Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed.

Time Frame

first 7 days of life

Title

Right ventricular (RV) function in ml/kg/min

Description

• RV output and stroke distance in main pulmonary artery: CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR.

Time Frame

first 7 days of life

Title

Left ventricular (LV)function in ml/kg/min

Description

LV output and stroke distance in ascending aorta: CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view). SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR.

Time Frame

first 7 days of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Hour

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial. Exclusion Criteria: • Diagnosis of PPHN discovered after more than 72 hours. Failure of used medications and need to administrate milrinone

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa M Farag

Phone

01288681788

Ext

+2

Email

d.marwa.farag@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hesham Ghazal, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Aly Mohamed Abdel-Mohsen, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Moataz Shawky Rezk, MD

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial