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WithdrawnNCT03499418PRE-HIFREQUpdated Oct 4, 2022

Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates

An observational study in Transient Tachypnea of the Newborn and PPHN, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Withdrawn at 1 site in Poland. Open to participants aged 10 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Observational

Why this study was withdrawn
Due to changing methodology of the study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
10 Minutes to 6 Hours
Sex
All
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Study 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).

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.

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Conditions studied

  • Transient Tachypnea of the Newborn
  • PPHN

Keywords

  • newborn
  • TTN
  • PPHN
03

In context

Transient Tachypnea of the Newborn

36 studies on the registry are indexed under Transient Tachypnea of the Newborn; 3 are open to participants now.

Browse Transient Tachypnea of the Newborn studies →

Lead sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Minutes to 6 Hours
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A signed form of 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • newborns with TTN

    Group of late preterm and full-term newborns with TTN evaluated by modified Silverman scale

    Other: modified Silverman scale

  • newborns with PPHN

    Group of late preterm and full-term newborns with respiratory failure with PPHN evaluated by echocardiography

    Other: modified Silverman scale · Diagnostic Test: echocardiography

Interventions

  • Othermodified Silverman scale

    Clinical assessment of severity of respiratory failure

  • Diagnostic testechocardiography

    echocardiographic evaluation of haemodynamic problems

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What researchers measure

Primary outcomes

  1. Rate of PPHN

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

    Time frame: 12 months

Secondary outcomes

  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)

    Time frame: 12 months

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Study locations

1 site
  • Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw
    Warsaw, 00-315, Poland
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2020; primary completion for Mar 2023, 29 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Apr 17, 2018
StartEst.
Oct 1, 2020
Primary completionEst.
Mar 31, 2023
CompletionEst.
Sep 30, 2024
Last update
Oct 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03499418
Lead sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Responsible party
Renata Bokiniec (MD, Clinical Professor, Head of Department of Neonatology, Princess Anna Mazowiecka Hospital, Warsaw, Poland) — Principal investigator
First posted
Apr 17, 2018
Start date
Oct 1, 2020 (estimated)
Primary completion
Mar 31, 2023 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Oct 4, 2022

Study contacts

Maria K. Borszewska-Kornacka, MD, ProfTit
study chair · Medical University of Warsaw

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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