PrematureNCT05095285
Pain and Comfort During Endotracheal Suction in Premature Neonates
A study testing Swaddling and Oropharyngeal colostrum in people with Premature, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Premature
- What is being tested?
- Swaddling and Oropharyngeal colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Oct 2020
- Phase
- Interventional
- 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 1 day to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational age of the baby is 26-36 weeks according to the mother's last menstrual period
- Baby's postnatal 0-5. be between days
- Receiving invasive mechanical ventilation support
- No analgesic, opioid and sedative pain relievers were administered in the 4 hours before the procedure.
- It has been 2 hours since the last painful attempt.
- Parental consent of the premature baby.
- Applying endotracheal suction at most 2 times since birth
Who cannot join
- Presence of congenital anomaly
- Having a history of convulsions
- Any extremity fracture/dislocation that will prevent wrapping
- Having a pneumothorax tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates.
Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses.
Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments.
Read more
Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies.
In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns.
In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.
Read the detailed description
The study was conducted experimentally in randomized controlled trials to determine the effect of two non-pharmacological methods, swaddling and oropharyngeal colostrum on procedural pain and comfort during endotracheal suction (ES) in premature neonates. The population of the study was intubated premature neonates hospitalized in NICU in two foundation university hospitals between July 2019 and October 2020. The study sample consisted of 48 babies who met the sample selection criteria. Descriptive Characteristics Form, Premature Infant Intervention Follow-up Form, Premature Infant Pain Profile-Revised (PIPP-R) and Newborn Comfort Behavior Scale (COMFORTneo) were used in data collection.
Two minutes before the ES procedure, babies were swaddled or 0.4 ml of oropharyngeal colostrum was given, depending on the group in which they were involved. Physiological parameters (heart rate, respiration, saturation) of the babies were recorded before, during and after the procedure, and PIPP-R and COMFORTneo scores were given by two observers by video recording.
- Conditions
- Premature
- Being tested
- Swaddling, Oropharyngeal colostrum
- Keywords
- endotracheal suction, pain, comfort, swaddling, colostrum
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwaddlingOther
- Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.
- Common procedure steps:
- Legal representatives of the infants will sign an informed consent form.
- İncubator cover and nesting
- Endotracheal suction(ES) was performed in the supine position.
- ES was done at the time of care the baby needed.
- No painful procedure was applied until 2 hours before ES and 15 minutes after ES.
- Aspiration was performed sterile at 80 mmHg pressure.
- A second nurse assisted in the suction process and the procedure took no more than 15 seconds.
- The amount of oxygen taken by the baby was increased by 10% 30 seconds before the suction procedure and returned to its original value 60 seconds after the procedure.
- Beginning 3 minutes before the ES procedure, during the procedure and until 15 minutes after the procedure, the infants' behaviors and bedside monitor indicators were video recorded.
Oropharyngeal colostrumOther
- Common procedure steps
- In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | • In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group. |
| The swaddling group | Experimental | •Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting. Receives: Other: Swaddling |
| The oropharyngeal colostrum group | Experimental | • In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue. Receives: Other: Oropharyngeal colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate
Heart rate will be monitored
Measured: Baby's heart rate will monitored during 20 minutes since it will start the camera record. (Heart rates will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Change in Oxygen Saturation
Oxygen saturation will be monitored
Measured: Baby's oxygen saturation will monitored during 20 minutes since it will start the camera record. (Oxygen Saturation will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Change in pain score
Pain score will be evaluated with Premature Infant Pain Profile-Revised (PIPP-R).
Measured: Baby's pain score will be evaluated during 20 minutes since it will start the camera record. (Pain score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Change in comfort score
Comfort score will be evaluated with Newborn Comfort Behavior Scale (COMFORTneo)
Measured: Baby's comfort score will be evaluated during 20 minutes since it will start the camera record. (Comfort score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Secondary outcomes (3)
Change in Respiratory Rate
Respiratory Rate will be monitored
Measured: Baby's respiratory rate will be monitored during 20 minutes since it will start the camera record. (Respiratory Rate will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Change in Body temperature
Body temperature will be measurement
Measured: Baby's body temperature will be measurement during 20 minutes since it will start the camera record. (Body temperature will be measurement at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Change in blood pressure
Blood pressure will be monitored
Measured: Baby's blood pressure will be monitored during 20 minutes since it will start the camera record. (Blood pressure will be monitored at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Jul 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huriye Karadede, Istanbul Aydın University
- Investigators
- Birsen Mutlu, Ass. Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095285
- Sponsor's protocol ID
- IstanbulAU
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desai S, Nanavati RN, Nathani R, Kabra N. Effect of Expressed Breast Milk versus Swaddling versus Oral Sucrose Administration on Pain Associated with Suctioning in Preterm Neonates on Assisted Ventilation: A Randomized Controlled Trial. Indian J Palliat Care. 2017 Oct-Dec;23(4):372-378. doi: 10.4103/IJPC.IJPC_84_17.
PubMed 29123341Taplak AS, Bayat M. Comparison the Effect of Breast Milk Smell, White Noise and Facilitated Tucking Applied to Turkish Preterm Infants During Endotracheal Suctioning on Pain and Physiological Parameters. J Pediatr Nurs. 2021 Jan-Feb;56:e19-e26. doi: 10.1016/j.pedn.2020.07.001. Epub 2020 Jul 18.
PubMed 32690406Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.
PubMed 24503979Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
PubMed 31229348Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
PubMed 32062050Kucuk Alemdar D, Guducu TufekcI F. Effects of maternal heart sounds on pain and comfort during aspiration in preterm infants. Jpn J Nurs Sci. 2018 Oct;15(4):330-339. doi: 10.1111/jjns.12202. Epub 2018 Jan 17.
PubMed 29345047Cardoso JM, Kusahara DM, Guinsburg R, Pedreira ML. Randomized crossover trial of endotracheal tube suctioning systems use in newborns. Nurs Crit Care. 2017 Sep;22(5):276-283. doi: 10.1111/nicc.12170. Epub 2015 Mar 16.
PubMed 25779636
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates.
- ClinicalTrials.gov ID
- NCT05095285
- Acronym / sponsor ID
- IstanbulAU
- Conditions
- Premature
- Keywords
- endotracheal suction, pain, comfort, swaddling, colostrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Oct 2021 (actual)
- 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.
Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses.
Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments.
Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies.
In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns.
In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.
Detailed description
The study was conducted experimentally in randomized controlled trials to determine the effect of two non-pharmacological methods, swaddling and oropharyngeal colostrum on procedural pain and comfort during endotracheal suction (ES) in premature neonates. The population of the study was intubated premature neonates hospitalized in NICU in two foundation university hospitals between July 2019 and October 2020. The study sample consisted of 48 babies who met the sample selection criteria. Descriptive Characteristics Form, Premature Infant Intervention Follow-up Form, Premature Infant Pain Profile-Revised (PIPP-R) and Newborn Comfort Behavior Scale (COMFORTneo) were used in data collection.
Two minutes before the ES procedure, babies were swaddled or 0.4 ml of oropharyngeal colostrum was given, depending on the group in which they were involved. Physiological parameters (heart rate, respiration, saturation) of the babies were recorded before, during and after the procedure, and PIPP-R and COMFORTneo scores were given by two observers by video recording.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group. |
| The swaddling group | Experimental | Other: Swaddling•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting. |
| The oropharyngeal colostrum group | Experimental | Other: Oropharyngeal colostrum• In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The gestational age of the baby is 26-36 weeks according to the mother's last menstrual period
- Baby's postnatal 0-5. be between days
- Receiving invasive mechanical ventilation support
- No analgesic, opioid and sedative pain relievers were administered in the 4 hours before the procedure.
- It has been 2 hours since the last painful attempt.
Key exclusion criteria (4 listed)
- Presence of congenital anomaly
- Having a history of convulsions
- Any extremity fracture/dislocation that will prevent wrapping
- Having a pneumothorax tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swaddling* Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting. * Common procedure steps: * Legal representatives of the infants will sign an informed consent form. * İncubator cover and nesting * Endotracheal suction(ES) was performed in the supine position. * ES was done at the time of care the baby needed. * No painful procedure was applied until 2 hours before ES and 15 minutes after ES. * Aspiration was performed sterile at 80 mmHg pressure. * A second nurse assisted in the suction process and the procedure took no more than 15 seconds. * The amount of oxygen taken by the baby was increased by 10% 30 seconds before the suction procedure and returned to its original value 60 seconds after the procedure. * Beginning 3 minutes before the ES procedure, during the procedure and until 15 minutes after the procedure, the infants' behaviors and bedside monitor indicators were video recorded. | Other | The swaddling group |
| Oropharyngeal colostrum* Common procedure steps * In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue. | Other | The oropharyngeal colostrum group |
Primary outcome
Change in Heart Rate
Time frame: Baby's heart rate will monitored during 20 minutes since it will start the camera record. (Heart rates will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Heart rate will be monitored
Change in Oxygen Saturation
Time frame: Baby's oxygen saturation will monitored during 20 minutes since it will start the camera record. (Oxygen Saturation will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Oxygen saturation will be monitored
Change in pain score
Time frame: Baby's pain score will be evaluated during 20 minutes since it will start the camera record. (Pain score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Pain score will be evaluated with Premature Infant Pain Profile-Revised (PIPP-R).
Change in comfort score
Time frame: Baby's comfort score will be evaluated during 20 minutes since it will start the camera record. (Comfort score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Comfort score will be evaluated with Newborn Comfort Behavior Scale (COMFORTneo)
3 secondary outcomes
Change in Respiratory Rate
Time frame: Baby's respiratory rate will be monitored during 20 minutes since it will start the camera record. (Respiratory Rate will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Change in Body temperature
Time frame: Baby's body temperature will be measurement during 20 minutes since it will start the camera record. (Body temperature will be measurement at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Change in blood pressure
Time frame: Baby's blood pressure will be monitored during 20 minutes since it will start the camera record. (Blood pressure will be monitored at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Results publication: PubMed 29123341Desai S, Nanavati RN, Nathani R, Kabra N. Effect of Expressed Breast Milk versus Swaddling versus Oral Sucrose Administration on Pain Associated with Suctioning in Preterm Neonates on Assisted Ventilation: A Randomized Controlled Trial. Indian J Palliat Care. 2017 Oct-Dec;23(4):372-378. doi: 10.4103/IJPC.IJPC_84_17.
- Results publication: PubMed 32690406Taplak AS, Bayat M. Comparison the Effect of Breast Milk Smell, White Noise and Facilitated Tucking Applied to Turkish Preterm Infants During Endotracheal Suctioning on Pain and Physiological Parameters. J Pediatr Nurs. 2021 Jan-Feb;56:e19-e26. doi: 10.1016/j.pedn.2020.07.001. Epub 2020 Jul 18.
- Results publication: PubMed 24503979Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.
- Results publication: PubMed 31229348Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
- Results publication: PubMed 32062050Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
- Results publication: PubMed 29345047Kucuk Alemdar D, Guducu TufekcI F. Effects of maternal heart sounds on pain and comfort during aspiration in preterm infants. Jpn J Nurs Sci. 2018 Oct;15(4):330-339. doi: 10.1111/jjns.12202. Epub 2018 Jan 17.
- Results publication: PubMed 25779636Cardoso JM, Kusahara DM, Guinsburg R, Pedreira ML. Randomized crossover trial of endotracheal tube suctioning systems use in newborns. Nurs Crit Care. 2017 Sep;22(5):276-283. doi: 10.1111/nicc.12170. Epub 2015 Mar 16.
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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.
Birsen Mutlu, Ass. Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swaddling and Oropharyngeal colostrum in people with Premature, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 27 Oct 2021. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Change in Heart Rate (time frame: Baby's heart rate will monitored during 20 minutes since it will start the camera record. (Heart rates will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095285, which also lists 7 linked publications.
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 27 Oct 2021.