NewbornNCT04293601
Pressure Injuries' Prevention in Newborn Infants Admitted to NICU
A study testing interventional nursing care and Standard nursing care in people with Newborn and Pressure Injury, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Newborn, Pressure Injury
- What is being tested?
- interventional nursing care and Standard nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2019to 16 May 2022
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent signed from both parents or legally authorized representative
- Infants receiving noninvasive respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) or Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV)
Who cannot join
- Pre-existing nasal lesion
Trial locations and contacts
1 site in 1 country.
Italy1 site
NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)
Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support.
The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi.
Read more
The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU.
It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.
Read the detailed description
Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors:
- Very Low birth weight (< 1500 g)
- Gestational age < 32 weeks
- NCPAP duration > 5 days
- NICU stay of > 14 days
However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP.
Interventions indicated as protective are:
- Appropriate size of mask or nasal prongs and headbands
- Use of hydrocolloid as nasal barrier dressing
- A frequent alternation of the NCPAP device (nasal prongs or mask)
- A frequent assessment of skin integrity In this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. The NICU clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present.
Hence, aim of this study is:
- To asses the effectiveness of specific nursing care interventions on the incidence of pressure injuries due to NCPAP support in neonates admitted to NICU.
- Conditions
- Newborn, Pressure Injury
- Being tested
- interventional nursing care, Standard nursing care
- Keywords
- Cpap, NICU, nasal trauma
- Medical subject headings
- Pressure Ulcer, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional nursing careOther
Also called prospective group
The infants enrolled will receive different intervention according to a defined risk factor level:
"Low":
- NCPAP duration < 48 hours (h)
- Gestational Age (GA) > 32 weeks (wks)
- Current weight > 1500 g
Interventions:
- alternating mask or nasal prongs once per shift
- skin assessment (excoriation, erythema or skin breakdown) once per shift
"Medium":
- NCPAP duration from 48 to 72 h
- GA from 32 to 28 wks
- Current weight from 1500 to 1000 g
Interventions:
- alternating mask or nasal prongs twice per shift
- skin assessment (excoriation, erythema or skin breakdown) twice per shift
- repositioning of device once per shift
"High":
- NCPAP duration > 72 h
- GA < 28 wks
- Current weight < 1000 g
Interventions:
- alternating mask or nasal prongs twice per shift
- skin assessment (excoriation, erythema or skin breakdown) every 3 h per shift
- repositioning of device every 3 h per shift
Standard nursing careOther
Also called retrospective group
- Use of hydrocolloid as nasal barrier dressing
- Appropriate size of headbands, indicated by production company
- Appropriate size of mask or binasal prongs, indicated by production company
- Frequently assess skin integrity, every 4 hours
- Replace hydrocolloid if it's dirty or displaced
- Humidity and heat gases
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All enrolled neonates will receive interventions that will be performed with different frequency and method according to newborns' risk factors, as well as the following standard interventions received by control group's newborns:
* appropriate use of hydrocolloid, headbands, masks and prongs
* frequently assess skin integrity
* humidity and heat gases Receives: Other: interventional nursing care |
| Standard care | Other | Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention" Receives: Other: Standard nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pressure nasal injuries
Evaluation of the number of pressure nasal injuries
Measured: Through study completion, an average of 27 months
Secondary outcomes (4)
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records
Measured: Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
Newborns' weight (grams) will be collected from electronical medical records
Measured: Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Duration NCPAP treatment
Duration NCPAP treatment (days) will be collected from electronical medical records
Measured: From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Duration of NICU stay
Duration of stay in NICU (days) will be collected from electronical medical records
Measured: From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start2 Dec 2019
- Primary completion2 Dec 2021
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Lagostina, RN, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293601
- Sponsor's protocol ID
- LesioniTIN/2019
- Status last verified
- May 2022
- First submitted
- 17 Feb 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen CY, Chou AK, Chen YL, Chou HC, Tsao PN, Hsieh WS. Quality Improvement of Nasal Continuous Positive Airway Pressure Therapy in Neonatal Intensive Care Unit. Pediatr Neonatol. 2017 Jun;58(3):229-235. doi: 10.1016/j.pedneo.2016.04.005. Epub 2016 Jul 26.
PubMed 27666491Imbulana DI, Manley BJ, Dawson JA, Davis PG, Owen LS. Nasal injury in preterm infants receiving non-invasive respiratory support: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F29-F35. doi: 10.1136/archdischild-2017-313418. Epub 2017 Sep 28.
PubMed 28970314Maruccia M, Fanelli B, Ruggieri M, Onesti MG. Necrosis of the columella associated with nasal continuous positive airway pressure in a preterm infant. Int Wound J. 2014 Jun;11(3):335-6. doi: 10.1111/j.1742-481X.2012.01121.x. Epub 2012 Nov 22. No abstract available.
PubMed 23173614Khan J, Sundaram V, Murki S, Bhatti A, Saini SS, Kumar P. Nasal injury and comfort with jet versus bubble continuous positive airway pressure delivery systems in preterm infants with respiratory distress. Eur J Pediatr. 2017 Dec;176(12):1629-1635. doi: 10.1007/s00431-017-3016-7. Epub 2017 Sep 15.
PubMed 28914355Arshadi M, Jabraeili M, Karimipoor S et al. The Efficacy of a Protocolized Nursing Care on Nasal Skin Breakdown in Preterm Neonates Receiving Nasal Continuous Positive Airway Pressure. International Journal of Pediatrics. 2017;5(1):4217-25.
Lagostina E, Ferrario S, Zorz A, Sorrentino G, Fassino B, Colnaghi M, Mosca F, Fumagalli M, Plevani L. Prevention of Pressure Injuries During Nasal Continuous Positive Airway Pressure in Newborns: A Non-pharmacological Intervention Trial. Nurs Crit Care. 2026 May;31(3):e70444. doi: 10.1111/nicc.70444.
PubMed 41846515
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)
- ClinicalTrials.gov ID
- NCT04293601
- Acronym / sponsor ID
- LesioniTIN/2019
- Conditions
- Newborn, Pressure Injury
- Keywords
- Cpap, NICU, nasal trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 3 Mar 2020 (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.
Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support.
The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi.
The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU.
It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.
Detailed description
Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors:
- Very Low birth weight (< 1500 g)
- Gestational age < 32 weeks
- NCPAP duration > 5 days
- NICU stay of > 14 days
However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP.
Interventions indicated as protective are:
- Appropriate size of mask or nasal prongs and headbands
- Use of hydrocolloid as nasal barrier dressing
- A frequent alternation of the NCPAP device (nasal prongs or mask)
- A frequent assessment of skin integrity In this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. The NICU clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present.
Hence, aim of this study is:
- To asses the effectiveness of specific nursing care interventions on the incidence of pressure injuries due to NCPAP support in neonates admitted to NICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: interventional nursing careAll enrolled neonates will receive interventions that will be performed with different frequency and method according to newborns' risk factors, as well as the following standard interventions received by control group's newborns: * appropriate use of hydrocolloid, headbands, masks and prongs * frequently assess skin integrity * humidity and heat gases |
| Standard care | Other | Other: Standard nursing careNewborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention" |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Informed consent signed from both parents or legally authorized representative
- Infants receiving noninvasive respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) or Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV)
Key exclusion criteria (1 listed)
- Pre-existing nasal lesion
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 |
|---|---|---|
| interventional nursing careAlso: prospective groupThe infants enrolled will receive different intervention according to a defined risk factor level: "Low": * NCPAP duration < 48 hours (h) * Gestational Age (GA) > 32 weeks (wks) * Current weight > 1500 g Interventions: * alternating mask or nasal prongs once per shift * skin assessment (excoriation, erythema or skin breakdown) once per shift "Medium": * NCPAP duration from 48 to 72 h * GA from 32 to 28 wks * Current weight from 1500 to 1000 g Interventions: * alternating mask or nasal prongs twice per shift * skin assessment (excoriation, erythema or skin breakdown) twice per shift * repositioning of device once per shift "High": * NCPAP duration > 72 h * GA < 28 wks * Current weight < 1000 g Interventions: * alternating mask or nasal prongs twice per shift * skin assessment (excoriation, erythema or skin breakdown) every 3 h per shift * repositioning of device every 3 h per shift | Other | Experimental group |
| Standard nursing careAlso: retrospective group* Use of hydrocolloid as nasal barrier dressing * Appropriate size of headbands, indicated by production company * Appropriate size of mask or binasal prongs, indicated by production company * Frequently assess skin integrity, every 4 hours * Replace hydrocolloid if it's dirty or displaced * Humidity and heat gases | Other | Standard care |
Primary outcome
Number of Pressure nasal injuries
Time frame: Through study completion, an average of 27 months
Evaluation of the number of pressure nasal injuries
4 secondary outcomes
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
Time frame: Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
Time frame: Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Duration NCPAP treatment
Time frame: From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Duration of NICU stay
Time frame: From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months
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 23 May 2022.
- Background: PubMed 27666491Chen CY, Chou AK, Chen YL, Chou HC, Tsao PN, Hsieh WS. Quality Improvement of Nasal Continuous Positive Airway Pressure Therapy in Neonatal Intensive Care Unit. Pediatr Neonatol. 2017 Jun;58(3):229-235. doi: 10.1016/j.pedneo.2016.04.005. Epub 2016 Jul 26.
- Background: PubMed 28970314Imbulana DI, Manley BJ, Dawson JA, Davis PG, Owen LS. Nasal injury in preterm infants receiving non-invasive respiratory support: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F29-F35. doi: 10.1136/archdischild-2017-313418. Epub 2017 Sep 28.
- Background: PubMed 23173614Maruccia M, Fanelli B, Ruggieri M, Onesti MG. Necrosis of the columella associated with nasal continuous positive airway pressure in a preterm infant. Int Wound J. 2014 Jun;11(3):335-6. doi: 10.1111/j.1742-481X.2012.01121.x. Epub 2012 Nov 22. No abstract available.
- Background: PubMed 28914355Khan J, Sundaram V, Murki S, Bhatti A, Saini SS, Kumar P. Nasal injury and comfort with jet versus bubble continuous positive airway pressure delivery systems in preterm infants with respiratory distress. Eur J Pediatr. 2017 Dec;176(12):1629-1635. doi: 10.1007/s00431-017-3016-7. Epub 2017 Sep 15.
- BackgroundArshadi M, Jabraeili M, Karimipoor S et al. The Efficacy of a Protocolized Nursing Care on Nasal Skin Breakdown in Preterm Neonates Receiving Nasal Continuous Positive Airway Pressure. International Journal of Pediatrics. 2017;5(1):4217-25.
- Derived from this study: PubMed 41846515Lagostina E, Ferrario S, Zorz A, Sorrentino G, Fassino B, Colnaghi M, Mosca F, Fumagalli M, Plevani L. Prevention of Pressure Injuries During Nasal Continuous Positive Airway Pressure in Newborns: A Non-pharmacological Intervention Trial. Nurs Crit Care. 2026 May;31(3):e70444. doi: 10.1111/nicc.70444.
- 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.
Elisa Lagostina, RN principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interventional nursing care and Standard nursing care in people with Newborn and Pressure Injury, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 23 May 2022. 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 Italy. 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?
Number of Pressure nasal injuries (time frame: Through study completion, an average of 27 months). 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 NCT04293601, which also lists 6 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 23 May 2022.