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Search / Trial NCT06217133

Heart Rate Variability of Premature Newborn

Launched by FEDERAL UNIVERSITY OF UBERLANDIA · Jan 11, 2024

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

Heart Rate Variability Neonatal Intensive Care Unit Non Invasive Ventilation

ClinConnect Summary

This clinical trial is studying the effects of two different breathing support methods, called CPAP, on the heart rate variability (HRV) of premature newborns. HRV is a measure that helps us understand how well a baby's body is responding to stress. The trial will compare conventional nasal CPAP with bubble CPAP to see if one method helps the baby's nervous system function better than the other. Researchers will monitor premature babies who are born between 28 and 32 weeks of gestation and are up to 12 days old, as long as they don’t have certain health issues like heart problems or serious congenital conditions.

Participants in the study will be placed in incubators and will have their heart rates recorded while using each type of CPAP for 24 hours at a time. The researchers will collect data several times a day to see how each method affects the babies’ heart rate and overall stress levels. It’s important to note that the trial is not yet recruiting participants, but it aims to find out which breathing support method may provide better care for premature newborns in the neonatal intensive care unit (NICU).

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All preterm infants between 28 and 32 weeks of gestation using nasal CPAP and who are at least 8 and at most 12 days old will be included in the study.
  • Exclusion Criteria:
  • hemodynamic instability,
  • hydroelectrolyte disorders that influence cardiac function,
  • post-operative,
  • congenital abnormalities,
  • pulmonary hypertension,
  • decompensated ductus arteriosus,
  • untreated atelectasis,
  • pneumothorax,
  • newborns who are using drains, whether chest or abdominal,
  • presence of necrotizing enterocolitis
  • grade 3 nasal septum injury,
  • signal captured without the necessary quality to be used in research,
  • premature babies who, for whatever reason, do not have two collections carried out on consecutive days until the twelfth day of life.

About Federal University Of Uberlandia

The Federal University of Uberlândia (Universidade Federal de Uberlândia, UFU) is a prominent academic institution in Brazil, renowned for its commitment to advancing research and education in the health sciences. As a clinical trial sponsor, UFU leverages its extensive resources and expertise to facilitate innovative research initiatives aimed at improving healthcare outcomes. The university fosters collaboration among multidisciplinary teams, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its clinical trials, UFU aims to contribute valuable insights to the scientific community and enhance patient care both locally and globally.

Locations

Patients applied

0 patients applied

Trial Officials

Lilian Rodrigues de Abreu Macedo, 3

Study Chair

Federal University of Uberlandia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported