Pulmonary FunctionNCT00749762
Pulmonary Function During Prone and Supine Positioning in NICU Infants Requiring Assisted Ventilation
An observational study of Pulmonary Function, run by University of Utah at 1 site in United States.
Trial summary
This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific improvements in pulmonary function which may occur when an infant is ventilated in the prone as compared to the supine position. Read more about this study
- Who is it for?
- Ages 24 hours to 6 months
- Conditions the study is for
- Pulmonary Function
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: For stable NICU infants who require assisted mechanical ventilation beginning after the 1st 24 hours of life and repeating every 2 to 7 days
Who may be able to join
- Any NICU patient who does not have a major congenital anomaly and is on assisted mechanical ventilation will be eligible for this study.
Who cannot join
- Healthy patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: Pulmonary Function During Prone and Supine Positioning in Neonatal Intensive Care Unit (NICU) Infants Requiring Assisted Ventilation
This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific improvements in pulmonary function which may occur when an infant is ventilated in the prone as compared to the supine position. Modest improvement in oxygen has been reported to occur with prone positioning, but the exact etiology for this change is not clear. A special incubator designed as an integrated care system allows routine care and the measurement of both patient and ventilator breaths during mechanical ventilation. This study will utilize this device to evaluate in NICU ventilated patients whether specific changes in pulmonary function accompany position changes, and whether these are correlated to a change in pulmonary gas exchange.
Read the detailed description
Healthy Newborns Pulmonary function and body positioning have been studied in term infants with special attention towards predisposing factors for sudden infant death syndrome.
No difference was seen between prone and supine positioning in functional residual capacity or in effective pulmonary blood flow in 12 normal newborn infants. In 39 healthy newborns, crying vital capacity and peak expiratory flow rate were decreased in prone position, suggesting that in the prone position lung volume is decreased and airway resistance is increased. In another study of 14 infants, prone position resulted in a 5 point (%) higher SpO2 and a 1.5 mL/kg increase in tidal volume, but no change in minute ventilation. In these infants fed while prone, sucking pressure and frequency were increased and suck duration was decreased. Diaphragm thickness appeared to be increased in the prone compared to the supine position, both at end inspiration and end expiration, in 16 healthy term infants undergoing ultrasonography, though SpO2, heart rate and respiratory rate were not different. In a study of an intubated one day old term infant with normal lungs, a novel technique using electrical impedance tomography measured a ventral shift in lung aeration in the prone position, and a dorsal shift in aeration in the supine position.
Healthy Preterm Infants In convalescing healthy premature infants, prone compared to supine positioning has been studied with attention to a possible relationship to the frequency and severity of central apnea (apnea of prematurity).
In one study of 22 preterm infants (mean birth weight and GA: 870 g, 27 wks) with symptomatic apnea and bradycardia, no differences in the frequency of apnea, bradycardia or desaturation episodes were noted between being positioned either prone or supine. However, a previous study in 14 stable preterm infants (mean GA 34 wks) with clinical apnea found an increase in apnea density and periodic breathing in the supine position. Similarly, in 55 infants with birth weight <1kg still on supplemental oxygen, the prone position was associated with a 2 point (%) increase in SpO2 and a decreased frequency of desaturation episodes. Another study saw a 7 mmHg increase in transcutaneous oxygen (TcPO2) associated with prone positioning and a significant decrease in the amount of chest wall asynchrony. Thoracoabdominal synchrony improved in the prone position in a study of 24 preterm infants (mean birth weight and GA: 1020 g, 28wks). One study of 11 infants (mean birth weight and GA: 1525 g, 32 wks) saw no differences in pulmonary function (tidal volume, minute ventilation, pulmonary resistance, dynamic compliance) between prone and supine position. Lung compliance, tidal volume and minute ventilation were higher in the prone position for 10 preterm infants (mean birth weight and GA: 2220 g, 35 wks), but so was total work of breathing. However, two other studies (N=45, N=7) have noted decreased work of breathing associated with the prone position in recovering preterm infants. Of interest, during apnea, the decrease in mean cerebral hemoglobin concentration and mean cerebral blood volume is less when premature infants are in the prone versus supine position.
Preterm Infants on Ventilators In a 1979 study of 14 preterm infants with RDS (mean birth weight and GA: 2250 g, 35 wks) at age 5d, prone compared to supine positioning resulted in a 11 mmHg increase in PaO2, a 50% increase in dynamic lung compliance, and a 22% increase in tidal volume. These improvements were enhanced if the dependent abdomen was unrestricted by suspending the infant in a specialized sling. As part of a study on episodic desaturation, it was noted that at 4 wks post natal age, the frequency of hypoxemic episodes decreased from 1.7 to 0.3 episodes per hour when 6 intubated VLBW infants were studied in the prone versus the supine position (mean birth weight \& GA: 810g, 26 wks). This was associated with a 3 point (%) higher baseline SpO2 and a 50% increase in minute ventilation. Desaturation episodes coincided with the onset of infant movement, and prone positioned infants initiated movement less frequently. A larger study of 25 intubated premature infants (mean birth weight and GA: 1633 g, 34 wks) found a 6 mmHg increase in PaO2 when infants were cared for in the prone compared to the supine position. Inspiratory and total pulmonary resistance in prone position were noted to be decreased for mechanical but not for spontaneous breaths in a study of 33 intubated premature infants (median birth weight \& GA: 82- g, 27 wks) after 2 weeks of age. A 2 point (%) increase in SpO2 was also noted. Twenty-eight intubated preterm infants (mean birth weight and GA: 1378 g, 30 wks) were studied prone and supine at 38h of age and were found to have lower motor activity scale scores, a 1 point (%) higher SpO2, and, in the 14 infants that experienced desaturation, fewer desaturation episodes in the prone position.
Summary
- Prone positioning appears to decrease movement activity in intubated and non-intubated premature infants and thus decrease the frequency of movement associated desaturation episodes.
- There is modest improvement in oxygenation (SpO2 or PaO2) when positioned prone in intubated and non-intubated premature infants.
- Only 4 published studies could be found (2 study with intubated preterm infants, 2 with non-intubated preterm infants) which examined pulmonary function testing during prone and supine positioning. Three studies reported improvement in pulmonary function with prone position, one study saw no change. The two studies involving intubated premature infants did not demonstrate improvements in the same pulmonary function parameters.
- Conditions
- Pulmonary Function
- Keywords
- DURING, PRONE, SUPINE, POSITIONING
- Medical subject headings
- Deception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startOct 2002
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Computers/hardware for data collection/storage are outdated and unserviceable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Donald .Null, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749762
- Sponsor's protocol ID
- 10831
- Status last verified
- May 2010
- First submitted
- 8 Sep 2008
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function During Prone and Supine Positioning in Neonatal Intensive Care Unit (NICU) Infants Requiring Assisted Ventilation
- ClinicalTrials.gov ID
- NCT00749762
- Acronym / sponsor ID
- 10831
- Conditions
- Pulmonary Function
- Keywords
- DURING, PRONE, SUPINE, POSITIONING
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Computers/hardware for data collection/storage are outdated and unserviceable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific improvements in pulmonary function which may occur when an infant is ventilated in the prone as compared to the supine position. Modest improvement in oxygen has been reported to occur with prone positioning, but the exact etiology for this change is not clear. A special incubator designed as an integrated care system allows routine care and the measurement of both patient and ventilator breaths during mechanical ventilation. This study will utilize this device to evaluate in NICU ventilated patients whether specific changes in pulmonary function accompany position changes, and whether these are correlated to a change in pulmonary gas exchange.
Detailed description
Healthy Newborns Pulmonary function and body positioning have been studied in term infants with special attention towards predisposing factors for sudden infant death syndrome.
No difference was seen between prone and supine positioning in functional residual capacity or in effective pulmonary blood flow in 12 normal newborn infants. In 39 healthy newborns, crying vital capacity and peak expiratory flow rate were decreased in prone position, suggesting that in the prone position lung volume is decreased and airway resistance is increased. In another study of 14 infants, prone position resulted in a 5 point (%) higher SpO2 and a 1.5 mL/kg increase in tidal volume, but no change in minute ventilation. In these infants fed while prone, sucking pressure and frequency were increased and suck duration was decreased. Diaphragm thickness appeared to be increased in the prone compared to the supine position, both at end inspiration and end expiration, in 16 healthy term infants undergoing ultrasonography, though SpO2, heart rate and respiratory rate were not different. In a study of an intubated one day old term infant with normal lungs, a novel technique using electrical impedance tomography measured a ventral shift in lung aeration in the prone position, and a dorsal shift in aeration in the supine position.
Healthy Preterm Infants In convalescing healthy premature infants, prone compared to supine positioning has been studied with attention to a possible relationship to the frequency and severity of central apnea (apnea of prematurity).
In one study of 22 preterm infants (mean birth weight and GA: 870 g, 27 wks) with symptomatic apnea and bradycardia, no differences in the frequency of apnea, bradycardia or desaturation episodes were noted between being positioned either prone or supine. However, a previous study in 14 stable preterm infants (mean GA 34 wks) with clinical apnea found an increase in apnea density and periodic breathing in the supine position. Similarly, in 55 infants with birth weight <1kg still on supplemental oxygen, the prone position was associated with a 2 point (%) increase in SpO2 and a decreased frequency of desaturation episodes. Another study saw a 7 mmHg increase in transcutaneous oxygen (TcPO2) associated with prone positioning and a significant decrease in the amount of chest wall asynchrony. Thoracoabdominal synchrony improved in the prone position in a study of 24 preterm infants (mean birth weight and GA: 1020 g, 28wks). One study of 11 infants (mean birth weight and GA: 1525 g, 32 wks) saw no differences in pulmonary function (tidal volume, minute ventilation, pulmonary resistance, dynamic compliance) between prone and supine position. Lung compliance, tidal volume and minute ventilation were higher in the prone position for 10 preterm infants (mean birth weight and GA: 2220 g, 35 wks), but so was total work of breathing. However, two other studies (N=45, N=7) have noted decreased work of breathing associated with the prone position in recovering preterm infants. Of interest, during apnea, the decrease in mean cerebral hemoglobin concentration and mean cerebral blood volume is less when premature infants are in the prone versus supine position.
Preterm Infants on Ventilators In a 1979 study of 14 preterm infants with RDS (mean birth weight and GA: 2250 g, 35 wks) at age 5d, prone compared to supine positioning resulted in a 11 mmHg increase in PaO2, a 50% increase in dynamic lung compliance, and a 22% increase in tidal volume. These improvements were enhanced if the dependent abdomen was unrestricted by suspending the infant in a specialized sling. As part of a study on episodic desaturation, it was noted that at 4 wks post natal age, the frequency of hypoxemic episodes decreased from 1.7 to 0.3 episodes per hour when 6 intubated VLBW infants were studied in the prone versus the supine position (mean birth weight \& GA: 810g, 26 wks). This was associated with a 3 point (%) higher baseline SpO2 and a 50% increase in minute ventilation. Desaturation episodes coincided with the onset of infant movement, and prone positioned infants initiated movement less frequently. A larger study of 25 intubated premature infants (mean birth weight and GA: 1633 g, 34 wks) found a 6 mmHg increase in PaO2 when infants were cared for in the prone compared to the supine position. Inspiratory and total pulmonary resistance in prone position were noted to be decreased for mechanical but not for spontaneous breaths in a study of 33 intubated premature infants (median birth weight \& GA: 82- g, 27 wks) after 2 weeks of age. A 2 point (%) increase in SpO2 was also noted. Twenty-eight intubated preterm infants (mean birth weight and GA: 1378 g, 30 wks) were studied prone and supine at 38h of age and were found to have lower motor activity scale scores, a 1 point (%) higher SpO2, and, in the 14 infants that experienced desaturation, fewer desaturation episodes in the prone position.
Summary
- Prone positioning appears to decrease movement activity in intubated and non-intubated premature infants and thus decrease the frequency of movement associated desaturation episodes.
- There is modest improvement in oxygenation (SpO2 or PaO2) when positioned prone in intubated and non-intubated premature infants.
- Only 4 published studies could be found (2 study with intubated preterm infants, 2 with non-intubated preterm infants) which examined pulmonary function testing during prone and supine positioning. Three studies reported improvement in pulmonary function with prone position, one study saw no change. The two studies involving intubated premature infants did not demonstrate improvements in the same pulmonary function parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 hours to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- For stable NICU infants who require assisted mechanical ventilation beginning after the 1st 24 hours of life and repeating every 2 to 7 days
Key inclusion criteria (1 listed)
- Any NICU patient who does not have a major congenital anomaly and is on assisted mechanical ventilation will be eligible for this study.
Key exclusion criteria (1 listed)
- Healthy patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald .Null, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Function, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.