Premature; InfantSIMPLSAFE3NCT06543589
Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
A study testing High-flow-nasal-cannula in people with Premature; Infant, run by Charles University, Czech Republic.
Trial summary
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. Read more about this study
- Who is it for?
- Ages 1 minute to 5 minutes
- Conditions the study is for
- Premature; Infant
- What is being tested?
- High-flow-nasal-cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Sep 2026
- 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 minute to 5 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.
- Written informed consent from parent/legal guardian(s) is obtained before delivery.
Who cannot join
- Peripartal hypoxia with pH < 7,1
- Significant congenital malformations.
- IUGR with estimated weight of fetus below 800g.
- Condition that has an adverse effect on breathing/ventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.
- Documented decision to give palliative neonatal care.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.
Read the detailed description
Background and Rationale
The stabilization of very premature infants (VPIs) immediately after birth is crucial, as their underdeveloped lungs are prone to respiratory distress. Non-invasive continuous positive airway pressure (CPAP) is commonly recommended in the delivery room and during transport to the NICU. While CPAP can help maintain airway pressure and support spontaneous breathing, its optimal pressure settings are not yet established. Furthermore, when CPAP pressure is increased for infants who are not breathing spontaneously, it often necessitates positive pressure ventilation (PPV), which may lead to lung injury and increase the risk of complications.
CPAP's reliance on a face mask requires frequent adjustments, which can trigger reflexes that may exacerbate bradycardia, potentially destabilizing the neonate. High-flow nasal cannula (HFNC) offers an alternative that reduces direct facial stimulation, thus potentially lowering the occurrence of these reflex-induced events. Preliminary studies suggest that HFNC is both feasible and effective in supporting some premature infants, though HFNC does not provide the precise pressure control seen with CPAP. This study is designed to evaluate if HFNC can provide effective airway pressure for initial lung clearance, decrease the need for PPV, and support safe respiratory stabilization of VPIs immediately after birth.
Hypothesis
HFNC will reduce upper airway resistance and deliver adequate positive pressure for lung aeration in spontaneously breathing, very immature neonates. Compared to CPAP, HFNC's reduced physical stimulation may decrease the requirement for PPV, promoting a smoother transition to stable lung function and cardiopulmonary stabilization in very preterm infants.
Trial Aim
This trial aims to compare the effectiveness and safety of HFNC and CPAP in stabilizing severely premature neonates in the delivery room and during transport to the NICU. The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth, to determine if HFNC can reduce the need for PPV more effectively than CPAP.
Objectives
The primary objective is to evaluate whether HFNC can reduce the need for PPV compared to CPAP in very premature infants immediately after birth. Secondary objectives will focus on achieving specific oxygenation and ventilation milestones without PPV, including SpO₂ levels and FiO₂ requirements.
Study Design
This is a stepped-wedge cluster randomized controlled trial (RCT) involving 10 tertiary perinatal care centers (9 in the Czech Republic, 1 in Slovakia). Participating centers will switch between using HFNC and CPAP during specified time periods. Randomization will determine the order in which each center uses either HFNC or CPAP across six to ten periods of approximately 90 days each.
- Conditions
- Premature; Infant
- Being tested
- High-flow-nasal-cannula
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow-nasal-cannulaDevice
Respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| ARM A (CPAP group) | No intervention | Infants randomized to the ARM A group will be stabilized on CPAP, according to the standard procedure of each participating center. |
| ARM B (HFNC group) | Experimental | For infants randomly assigned to the ARM B group, the respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula. Receives: Device: High-flow-nasal-cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive pressure ventilation (PPV)
The primary endpoint of the trial is to demonstrate a difference in the proportion of neonates requiring PPV administration in the delivery room during the first 10 minutes post-birth.
This will be recorded as a binary outcome (yes/no) indicating whether PPV was administered. Each neonate's need for PPV should be documented by the clinical team and recorded in a standardized data collection form immediately after delivery.
Measured: 10 minutes after delivery
Secondary outcomes (3)
SpO2 >80% within the first 5 minutes of life
Achieving SpO2 >80% within the first 5 minutes of life, regardless of FiO2 without the need of PPV administration.
Oxygen saturation (SpO₂) will be measured continuously using a pulse oximeter attached to the infant.
Measured: 5 minutes after delivery
SpO2 >90% with FiO2 ≤ 0.40 within the first 10 minutes of life
Achieving SpO2 >90% with FiO2 ≤ 0.40 within the first 10 minutes of life without the need for PPV.
Oxygen saturation (SpO₂) will be measured continuously using a pulse oximeter attached to the infant.
Measured: 10 minutes after delivery
Stabilization on selected ventilatory support
Stabilization on selected ventilatory support with FiO2 ≤ 0.35 without the use of PPV at 3h of life.
FiO₂ and respiratory support (CPAP or HFNC) will be documented.
Measured: 3 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startDec 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Premature; InfantStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The randomization unit in this study is the center, rather than individual patients. Centers will be randomized to either the ARM A or ARM B at each time period using a stepped-wedge cluster-randomized design. A randomization schedule will be generated using a computer-based random number generator to ensure unbiased allocation. At each of the specified time periods, a random subset of centers will be selected to switch from control to intervention. While it is not feasible to blind the centers to their intervention status due to the nature of the study, the data analysts will be blinded to the group assignments to minimize bias. The randomization will be implemented by the study coordinator, who will notify each center of their assignment at the beginning of each time period. This approach ensures that each center will eventually receive the intervention, allowing for both within-center and between-center comparisons, thus enhancing the robustness of the study findings.
- Masking
- None (open label)
- Enrolment
- 443 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonáš Klára, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543589
- Sponsor's protocol ID
- 8/24
- Acronym
- SIMPLSAFE3
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
PubMed 33773829Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660.
PubMed 30912836Lista G, Cavigioli F, La Verde PA, Castoldi F, Bresesti I, Morley CJ. Effects of Breathing and Apnoea during Sustained Inflations in Resuscitation of Preterm Infants. Neonatology. 2017;111(4):360-366. doi: 10.1159/000454799. Epub 2017 Jan 25.
PubMed 28118641Martherus T, Oberthuer A, Dekker J, Hooper SB, McGillick EV, Kribs A, Te Pas AB. Supporting breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2019 Jan;104(1):F102-F107. doi: 10.1136/archdischild-2018-314898. Epub 2018 Jul 26.
PubMed 30049727Kuypers K, Martherus T, Lamberska T, Dekker J, Hooper SB, Te Pas AB. Reflexes that impact spontaneous breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):675-679. doi: 10.1136/archdischild-2020-318915. Epub 2020 Apr 29.
PubMed 32350064Kuypers KLAM, Hopman A, Cramer SJE, Dekker J, Visser R, Hooper SB, Te Pas AB. Effect of initial and subsequent mask applications on breathing and heart rate in preterm infants at birth. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):594-598. doi: 10.1136/archdischild-2022-324835. Epub 2023 Apr 20.
PubMed 37080734Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5.
PubMed 26733541Siva NV, Reynolds PR. Stabilisation of the preterm infant in the delivery room using nasal high flow: A 5-year retrospective analysis. Acta Paediatr. 2021 Jul;110(7):2065-2071. doi: 10.1111/apa.15824. Epub 2021 Mar 8.
PubMed 33638878Roberts CT, Hodgson KA. Nasal high flow treatment in preterm infants. Matern Health Neonatol Perinatol. 2017 Sep 6;3:15. doi: 10.1186/s40748-017-0056-y. eCollection 2017.
PubMed 28904810Mazmanyan P, Darakchyan M, Pinkham MI, Tatkov S. Mechanisms of nasal high flow therapy in newborns. J Appl Physiol (1985). 2020 Apr 1;128(4):822-829. doi: 10.1152/japplphysiol.00871.2019. Epub 2020 Feb 20.
PubMed 32078463Bjorland PA, Oymar K, Ersdal HL, Rettedal SI. Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open. 2019 Dec 29;3(1):e000592. doi: 10.1136/bmjpo-2019-000592. eCollection 2019.
PubMed 31909225Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.
PubMed 27653564Manley BJ, Arnolda GRB, Wright IMR, Owen LS, Foster JP, Huang L, Roberts CT, Clark TL, Fan WQ, Fang AYW, Marshall IR, Pszczola RJ, Davis PG, Buckmaster AG; HUNTER Trial Investigators. Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries. N Engl J Med. 2019 May 23;380(21):2031-2040. doi: 10.1056/NEJMoa1812077.
PubMed 31116919Lamberska T, Jonas K, Borcinova M, Ophir Y, Plavka R. High-flow nasal cannula versus continuous positive airway pressure for initial respiratory support in very preterm infants: study protocol for a multicenter randomized controlled trial (SIMPLSAFE3). Trials. 2026 Jun 12;27(1):439. doi: 10.1186/s13063-026-09816-y.
PubMed 42286746
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
- ClinicalTrials.gov ID
- NCT06543589
- Acronym / sponsor ID
- SIMPLSAFE3 / 8/24
- Conditions
- Premature; Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 443 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.
Detailed description
Background and Rationale
The stabilization of very premature infants (VPIs) immediately after birth is crucial, as their underdeveloped lungs are prone to respiratory distress. Non-invasive continuous positive airway pressure (CPAP) is commonly recommended in the delivery room and during transport to the NICU. While CPAP can help maintain airway pressure and support spontaneous breathing, its optimal pressure settings are not yet established. Furthermore, when CPAP pressure is increased for infants who are not breathing spontaneously, it often necessitates positive pressure ventilation (PPV), which may lead to lung injury and increase the risk of complications.
CPAP's reliance on a face mask requires frequent adjustments, which can trigger reflexes that may exacerbate bradycardia, potentially destabilizing the neonate. High-flow nasal cannula (HFNC) offers an alternative that reduces direct facial stimulation, thus potentially lowering the occurrence of these reflex-induced events. Preliminary studies suggest that HFNC is both feasible and effective in supporting some premature infants, though HFNC does not provide the precise pressure control seen with CPAP. This study is designed to evaluate if HFNC can provide effective airway pressure for initial lung clearance, decrease the need for PPV, and support safe respiratory stabilization of VPIs immediately after birth.
Hypothesis
HFNC will reduce upper airway resistance and deliver adequate positive pressure for lung aeration in spontaneously breathing, very immature neonates. Compared to CPAP, HFNC's reduced physical stimulation may decrease the requirement for PPV, promoting a smoother transition to stable lung function and cardiopulmonary stabilization in very preterm infants.
Trial Aim
This trial aims to compare the effectiveness and safety of HFNC and CPAP in stabilizing severely premature neonates in the delivery room and during transport to the NICU. The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth, to determine if HFNC can reduce the need for PPV more effectively than CPAP.
Objectives
The primary objective is to evaluate whether HFNC can reduce the need for PPV compared to CPAP in very premature infants immediately after birth. Secondary objectives will focus on achieving specific oxygenation and ventilation milestones without PPV, including SpO₂ levels and FiO₂ requirements.
Study Design
This is a stepped-wedge cluster randomized controlled trial (RCT) involving 10 tertiary perinatal care centers (9 in the Czech Republic, 1 in Slovakia). Participating centers will switch between using HFNC and CPAP during specified time periods. Randomization will determine the order in which each center uses either HFNC or CPAP across six to ten periods of approximately 90 days each.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization unit in this study is the center, rather than individual patients. Centers will be randomized to either the ARM A or ARM B at each time period using a stepped-wedge cluster-randomized design. A randomization schedule will be generated using a computer-based random number generator to ensure unbiased allocation. At each of the specified time periods, a random subset of centers will be selected to switch from control to intervention. While it is not feasible to blind the centers to their intervention status due to the nature of the study, the data analysts will be blinded to the group assignments to minimize bias. The randomization will be implemented by the study coordinator, who will notify each center of their assignment at the beginning of each time period. This approach ensures that each center will eventually receive the intervention, allowing for both within-center and between-center comparisons, thus enhancing the robustness of the study findings.
| Arm | Type | Receives |
|---|---|---|
| ARM A (CPAP group) | No intervention | –Infants randomized to the ARM A group will be stabilized on CPAP, according to the standard procedure of each participating center. |
| ARM B (HFNC group) | Experimental | Device: High-flow-nasal-cannulaFor infants randomly assigned to the ARM B group, the respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula. |
Who may qualify
- Ages
- 1 minute to 5 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.
- Written informed consent from parent/legal guardian(s) is obtained before delivery.
Key exclusion criteria (5 listed)
- Peripartal hypoxia with pH < 7,1
- Significant congenital malformations.
- IUGR with estimated weight of fetus below 800g.
- Condition that has an adverse effect on breathing/ventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.
- Documented decision to give palliative neonatal care.
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 |
|---|---|---|
| High-flow-nasal-cannulaRespiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula. | Device | ARM B (HFNC group) |
Primary outcome
Positive pressure ventilation (PPV)
Time frame: 10 minutes after delivery
The primary endpoint of the trial is to demonstrate a difference in the proportion of neonates requiring PPV administration in the delivery room during the first 10 minutes post-birth. This will be recorded as a binary outcome (yes/no) indicating whether PPV was administered. Each neonate's need for PPV should be documented by the clinical team and recorded in a standardized data collection form immediately after delivery.
3 secondary outcomes
SpO2 >80% within the first 5 minutes of life
Time frame: 5 minutes after delivery
SpO2 >90% with FiO2 ≤ 0.40 within the first 10 minutes of life
Time frame: 10 minutes after delivery
Stabilization on selected ventilatory support
Time frame: 3 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 33773829Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
- Background: PubMed 30912836Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660.
- Background: PubMed 28118641Lista G, Cavigioli F, La Verde PA, Castoldi F, Bresesti I, Morley CJ. Effects of Breathing and Apnoea during Sustained Inflations in Resuscitation of Preterm Infants. Neonatology. 2017;111(4):360-366. doi: 10.1159/000454799. Epub 2017 Jan 25.
- Background: PubMed 30049727Martherus T, Oberthuer A, Dekker J, Hooper SB, McGillick EV, Kribs A, Te Pas AB. Supporting breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2019 Jan;104(1):F102-F107. doi: 10.1136/archdischild-2018-314898. Epub 2018 Jul 26.
- Background: PubMed 32350064Kuypers K, Martherus T, Lamberska T, Dekker J, Hooper SB, Te Pas AB. Reflexes that impact spontaneous breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):675-679. doi: 10.1136/archdischild-2020-318915. Epub 2020 Apr 29.
- Background: PubMed 37080734Kuypers KLAM, Hopman A, Cramer SJE, Dekker J, Visser R, Hooper SB, Te Pas AB. Effect of initial and subsequent mask applications on breathing and heart rate in preterm infants at birth. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):594-598. doi: 10.1136/archdischild-2022-324835. Epub 2023 Apr 20.
- Background: PubMed 26733541Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5.
- Background: PubMed 33638878Siva NV, Reynolds PR. Stabilisation of the preterm infant in the delivery room using nasal high flow: A 5-year retrospective analysis. Acta Paediatr. 2021 Jul;110(7):2065-2071. doi: 10.1111/apa.15824. Epub 2021 Mar 8.
- Background: PubMed 28904810Roberts CT, Hodgson KA. Nasal high flow treatment in preterm infants. Matern Health Neonatol Perinatol. 2017 Sep 6;3:15. doi: 10.1186/s40748-017-0056-y. eCollection 2017.
- Background: PubMed 32078463Mazmanyan P, Darakchyan M, Pinkham MI, Tatkov S. Mechanisms of nasal high flow therapy in newborns. J Appl Physiol (1985). 2020 Apr 1;128(4):822-829. doi: 10.1152/japplphysiol.00871.2019. Epub 2020 Feb 20.
- Background: PubMed 31909225Bjorland PA, Oymar K, Ersdal HL, Rettedal SI. Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open. 2019 Dec 29;3(1):e000592. doi: 10.1136/bmjpo-2019-000592. eCollection 2019.
- Background: PubMed 27653564Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow-nasal-cannula in people with Premature; Infant, run by Charles University, Czech Republic.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tereza Lamberska, PhD (+4202249674444, tereza.lamberska@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive pressure ventilation (PPV) (time frame: 10 minutes after delivery). 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 NCT06543589, which also lists 14 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 12 Nov 2024.