Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Официальное название

Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension

Обзор

Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.

Подробное описание

Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention).

Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.

Вмешательства

• Устройство higher oxygen saturation target using Nellcor pulse oximetry sensors
  The intervention will be a cross over exposure to the higher oxygen saturation target.
• Устройство lower oxygen saturation target using Nellcor pulse oximetry sensors
  The intervention will be a cross over exposure to the lower oxygen saturation target.

Первичные конечные точки

• Intermittent hypoxemia event duration [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]

Вторичные конечные точки (6)

• Echocardiographic shunting [Срок оценки: through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
• Echocardiographic interventricular septal flattening [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
• Echocardiographic tricuspid regurgitation [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
• Intermittent hypoxemia frequency [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
• Cumulative hypoxemia [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
• Brain natriuretic peptide [Срок оценки: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]

Критерии участия

Критерии включения

• Between 22w 0/7d and 31w 6/7d gestation at birth
• Diagnosed with echocardiographic pulmonary hypertension (1) >20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index >1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg
• Receiving supplemental oxygen
• Have mature retinas

Критерии исключения

• Major congenital anomalies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• The University of Alabama at Birmingham — Birmingham
• Yale New Haven Hospital — New Haven

Идентификаторы

NCT: NCT06373289 · 000539476 · 1K23HD113837-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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