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Transient Tachypnea of the NewbornPRE-HIFREQNCT03499418

Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates

An observational study of Transient Tachypnea of the Newborn and PPHN, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 minutes to 6 hours
Conditions the study is for
Transient Tachypnea of the Newborn, PPHN
What is being tested?
modified Silverman scale and echocardiography
How many people
0 participants
Where
1 sitePoland
Study dates
1 Oct 2020to 30 Sep 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 minutes to 6 hours
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw

    Warsaw, 00-315

Other trials in Poland

About this study

Official title: Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Term and Near-term Neonates - Observational Study

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).

Read the 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.

Being tested
modified Silverman scale, echocardiography
Keywords
newborn, TTN, PPHN
Medical subject headings
Transient Tachypnea of the Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified Silverman scaleOther

    Clinical assessment of severity of respiratory failure

  • echocardiographyDiagnostic test

    echocardiographic evaluation of haemodynamic problems

Study groups in NCT03499418
Study groupRoleWhat they receive
newborns with TTNGroup of late preterm and full-term newborns with TTN evaluated by modified Silverman scale
Receives: Other: modified Silverman scale
newborns with PPHNGroup of late preterm and full-term newborns with respiratory failure with PPHN evaluated by echocardiography
Receives: Other: modified Silverman scale; Diagnostic Test: echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of PPHN

    The primary endpoint for this study is time of respiratory failure (need to intubation) and incidence rate of PPHN

    Measured: 12 months

Secondary outcomes (1)
  1. The evaluation of the "TTN scale"

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

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Why it stopped: Due to changing methodology of the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499418
Sponsor's protocol ID
PRE-HIFREQ
Acronym
PRE-HIFREQ
Status last verified
Sep 2022
First submitted
19 Oct 2017
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Raju TN, Higgins RD, Stark AR, Leveno KJ. Optimizing care and outcome for late-preterm (near-term) infants: a summary of the workshop sponsored by the National Institute of Child Health and Human Development. Pediatrics. 2006 Sep;118(3):1207-14. doi: 10.1542/peds.2006-0018.

    PubMed 16951017
  • Rubaltelli FF, Dani C, Reali MF, Bertini G, Wiechmann L, Tangucci M, Spagnolo A. Acute neonatal respiratory distress in Italy: a one-year prospective study. Italian Group of Neonatal Pneumology. Acta Paediatr. 1998 Dec;87(12):1261-8. doi: 10.1080/080352598750030951.

    PubMed 9894827
  • Lakshminrusimha S, Keszler M. Persistent Pulmonary Hypertension of the Newborn. Neoreviews. 2015 Dec;16(12):e680-e692. doi: 10.1542/neo.16-12-e680.

    PubMed 26783388
  • Buchiboyina A, Jasani B, Deshmukh M, Patole S. Strategies for managing transient tachypnoea of the newborn - a systematic review. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1524-1532. doi: 10.1080/14767058.2016.1193143. Epub 2016 Oct 20.

    PubMed 27762156

Questions about this trial

What is this clinical trial studying?

An observational study of Transient Tachypnea of the Newborn and PPHN, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of PPHN (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03499418, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

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