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Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates (PRE-HIFREQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03499418
Recruitment Status : Unknown
Verified April 2018 by Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland.
Recruitment status was:  Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland

Brief Summary:

Transient Tachypnea of the Newborn (TTN) is one of the common causes of neonatal respiratory distress as a result of delayed clearance of fetal lung fluid.

Neonates with TTN usually require noninvasive respiratory support (e.g. nasal cannula, nasal CPAP) and may need supplemental oxygen therapy to maintain normal oxygen saturation levels. There have also been reports of "malignant TTN," in which affected children develop persistent pulmonary hypertension of the newborn (PPHN).

Condition or disease Intervention/treatment
Transient Tachypnea of the Newborn PPHN Other: modified Silverman scale Diagnostic Test: echocardiography

Detailed Description:

Respiratory failure after birth is still a severe problem. Risk factors include premature labor and delivery by cesarean section. Despite the improvement of the quality of perinatal care in Poland, almost a constant percentage of premature babies has been born in Poland. The number of births by cesarean section is also rising - both planned and preceded by the attempt to vaginal delivery. TTN - Transient Tachypnea of the Newborn is one of the most common causes of respiratory failure in newborns. TTN occurs in approximately 10% of newborns born between 33 and 34 weeks of gestation, in about 5% of newborns born between 35 and 36 weeks and less than 1% of neonates.

At baseline of transient tachypnea of the newborn (TTN), there are disorders of absorption of pulmonary fluid. In the flow of water, epithelial sodium channels and Na+ / K+ -ATPase play an essential role. Their stimulation increases the absorption of water from the lung airspace and increases its transport both inside and outside the cell. In the subsequent stages of removal of interstitial pulmonary fluid, the vascular system and the lymphatic system are involved.

TTN is usually a self-limiting process, and treatments are not defined. There are also reports of "malignant TTN" in which infants develop persistent pulmonary hypertension of newborns (PPHN) (3). TTN infants typically require non-invasive respiratory support (CPAP, for example) and may need higher oxygen concentrations in the respiratory mixture to maintain proper oxygenation. Some experts suggest that the early use of expanding pressure (nasal CPAP) may relieve severe forms of TTN and prevent using of mechanical ventilation, and also may eventually prevent the development of persistent pulmonary hypertension.

Persistent pulmonary hypertension of newborns (PPHN) is a disorder arising at the stage of a physiological passage of fetal circulation into the neonatal circulation in the perinatal period. It is associated with a lack of decreasing pulmonary vascular resistance, which is influenced by increasing levels of oxygen in the blood and numerous biochemical and hormonal factors. From own observations and data from the literature, it is estimated that PPHN occurs in approximately 0.1-0.2% of newborns born term or near the term. Treatment of persistent pulmonary hypertension is difficult. Despite the use of mechanical ventilation, inhaled nitric oxide (iNO) or extracorporeal oxygenation (ECMO), the risk of death is still around 10-15%. This percentage has declined in recent years, but it is believed that persistent pulmonary hypertension of newborns is one of the most challenging situations in intensive care of newborns. In addition, infants who have undergone PPHN are exposed to long-term effects in the form of neurological complications or neurodevelopmental disorders.

Before initiating a clinical trial (intervention) with the experimental therapy, an initial follow-up study was conducted to assess the incidence of failure in respiratory insufficiency and the rate of PPHN in neonates born between 32 and 41 weeks of gestation. The failure of treatment will be defined as the need for invasive ventilation (intubation and mechanical ventilation). To accurately determine the degree of respiratory failure, a scale was developed that was an adaptation of the Silverman scale. PPHN will be defined by parameters measured in echocardiography and on changes in blood gases. Also, a comparison of parameters of acid-base balance and the type of treatment of respiratory failure after birth will be performed in the follow-up study. Based on the collected data, validation of the modified Silverman scale and evaluation of its clinical utility will be presented.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Term and Near-term Neonates - Observational Study
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : October 31, 2019

Group/Cohort Intervention/treatment
newborns with TTN
Group of late preterm and full-term newborns with TTN evaluated by modified Silverman scale
Other: modified Silverman scale
Clinical assessment of severity of respiratory failure

newborns with PPHN
Group of late preterm and full-term newborns with respiratory failure with PPHN evaluated by echocardiography
Other: modified Silverman scale
Clinical assessment of severity of respiratory failure

Diagnostic Test: echocardiography
echocardiographic evaluation of haemodynamic problems

Primary Outcome Measures :
  1. Rate of PPHN [ Time Frame: 12 months ]
    The primary endpoint for this study is time of respiratory failure (need to intubation) and incidence rate of PPHN

Secondary Outcome Measures :
  1. The evaluation of the "TTN scale" [ Time Frame: 12 months ]

    The evaluation of the "TTN scale" in comparison to physiologic parameters:

    • Fraction of inspired oxygen (FiO2)
    • pH
    • Partial pressure of carbon dioxide (pCO2)

Biospecimen Retention:   Samples Without DNA
blood gases

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is a multicenter, prospective, cohort, observational to assess the clinical benefits of using a scale in a population of neonates from 32 to 41 completed weeks PMA who will be admitted to a neonatal intensive care unit (NICU). Before study enrollment, parents (legal guardians) will provide a signed written informed consent form (ICF). ICF form may be signed after subject met inclusion criteria for the study.

Inclusion Criteria:

  • A signed form of informed consent from parents (legal guardians).
  • 32 0/7 to 41 6/7 weeks of gestation
  • The need to support postnatal breathing, no later than 6 hours of life.

Exclusion Criteria:

  • The need for intubation in the after-birth procedures
  • Age above 6 hours of age from birth
  • Congenital heart defects
  • Congenital diaphragmatic hernia
  • Other severe congenital malformations and genetically determined syndromes, diagnosed before and after birth, associated with higher risk of respiratory failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03499418

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Contact: Dariusz P. Madajczak, MD, PhD +48225966155
Contact: Renata Bokiniec, MD, PhD +48225966136

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Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw
Warsaw, Poland, 00-315
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
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Study Chair: Maria K. Borszewska-Kornacka, MD, ProfTit Medical University of Warsaw

Additional Information:

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Responsible Party: Renata Bokiniec, MD, PhD, Princess Anna Mazowiecka Hospital, Warsaw, Poland Identifier: NCT03499418    
Other Study ID Numbers: PRE-HIFREQ
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland:
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Transient Tachypnea of the Newborn
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Infant, Premature, Diseases
Infant, Newborn, Diseases