Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates

NCT03499418 | Withdrawn

• 1 other identifier: PRE-HIFREQ
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Transient Tachypnea of the Newborn; PPHN

Keywords

newborn; TTN; PPHN

Outcome Measures

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

  12 months

Secondary Outcomes (1)

• The evaluation of the "TTN scale"

  12 months

Study Arms (2)

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

modified Silverman scale OTHER

Clinical assessment of severity of respiratory failure

newborns with PPHN; newborns with TTN

echocardiography DIAGNOSTIC_TEST

echocardiographic evaluation of haemodynamic problems

newborns with PPHN

Eligibility Criteria

• Age: 10 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead

Study Sites (1)

Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw

Warsaw, 00-315, Poland

Location

Related Publications (4)

• 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.

  PMID: 16951017 BACKGROUND

• 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.

  PMID: 9894827 BACKGROUND

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

  PMID: 26783388 BACKGROUND

• 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.

  PMID: 27762156 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood gases

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Maria K. Borszewska-Kornacka, MD, ProfTit

  Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Professor, Head of Department of Neonatology

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: April 17, 2018
• Study Start: October 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

PL (1)