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NCT Number: NCT04639583

Use of NIRS in Preterm Population Born at Altitude

Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.

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Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant must be <32 weeks' gestational age at time of delivery.
  • Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
  • Infants that require blood transfusions during the monitoring time may be included.

Exclusion criteria

  • Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
  • Infant born after placental abruption or concern for extreme blood loss immediately after birth.
  • Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
  • Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
  • Mothers/guardians that are <18 years of age will not be approached for consent.
  • Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study.
  • Any infant that is planned to be placed for adoption
  • Infant is greater than 24 hours of age at time of consent.

Treatment and study plan

Near-infrared spectroscopy (NIRS) utilization

Device

The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.

Primary outcomes

  1. Cerebral Regional Oxygen Saturation (cRSO2)

    Time frame: first 96 hours of life

    Measure cRSO2 for the first 96 hours of life in infants born preterm.

Secondary outcomes

  1. Incidence of Major Complications of Prematurity

    Time frame: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.

    Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2020
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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