Premature Birth of NewbornNCT02306317
The Adding Value of Parents to Nursing Care in the Control of FiO2
A study testing Standard procedure and Experimental procedure in people with Premature Birth of Newborn, run by Carmen Rosa Pallas at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. Read more about this study
- Who is it for?
- Ages 7 days to 9 months
- Conditions the study is for
- Premature Birth of Newborn
- What is being tested?
- Standard procedure and Experimental procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Jun 2018
- 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 7 days to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Related to child
- Preterm neonates less than 32 weeks or less than 1500 g hospitalized in the Neonatal Intensive Care Unit at Hospital 12 de Octubre.
- Receiving supplemental oxygen ≤0.4 administered by CPAP or conventional nasal cannula or high flow or children with BiPAP (flow generator with double level pressure)
- Minimum age 7 days old.
- Related to the mother:
- Absence of health problems that allows her to perform the task.
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- Availability to frequently visit her baby with the father or with a companion, at least for 20 hours, not consecutive.
- Understanding of the study and the Spanish language by the mother and father or companion.
- Signed informed consent.
Who cannot join
- Evidence of pneumothorax or pneumomediastinum.
- Non-compliance with study protocol.
- Requiring treatment with vasoactive drugs.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Carmen R. Pallás Alonso, Dra, 34 913908272
M. Dolores Martín Pelegrina, Dra., 34 913908272
About this study
Official title: Changing the Paradigm for Improving Neonatal Care: Clinical Study on Optimal Oxygen-saturation Time and the Adding Value of Parents to Nursing Care in the Control of Fi02
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. If the hypothesis of this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their children admitted in a neonatal intensive care unit.
Read the detailed description
Both episodes of hyperoxia and hypoxemia in preterm infants increase morbidity and mortality. Nowadays the adjustment of FiO2 is manually controlled, which means it depends on the staff, needing multiple adjustments throughout the day.
The investigators's hypothesis is that the FiO2 control by parents, improve the percentage of time in range of optimum saturation at least 10% compared to control by nurses.
The aim of this study is to compare the proportion of time with oxygen saturation (SpO2) within the assigned target range, in the preterm infants whose parents modify the fraction of inspired oxygen (FiO2) versus the nursing staff modifying group.
This is a randomized controlled clinical study in the neonatal intensive care unit at Hospital 12 de Octubre. Patients will be randomized in two groups, Experimental Group: parents controlling the saturation ranges, they will manually adjust FiO2 versus the Control Group: controlled by nursing staff (standard procedure). Saturations will be registered and adjustments of FiO2 will be filmed for nonconsecutive 20-hours periods. Twenty-three patients will be enrolled in each group.
- Conditions
- Premature Birth of Newborn
- Being tested
- Standard procedure, Experimental procedure
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard procedureOther
FiO2 manually controlled by nursing
Experimental procedureOther
FiO2 manually controlled by parents, after training.
| Study group | Role | What they receive |
|---|---|---|
| Control by nursing. | Active comparator | FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure Receives: Other: Standard procedure |
| Control by parents. | Experimental | FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure Receives: Other: Experimental procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children maintained within the saturation ranges in each group
Percentage of time the child is kept within the ranges of saturation in each group
Measured: 20-40 hours as maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Rosa Pallas
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor-investigator, Carmen Rosa Pallas, Hospital Universitario 12 de Octubre
- Investigators
- Carmen R. Pallás Alonso, Dra., Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306317
- Sponsor's protocol ID
- Neonatología-2014-01
- Status last verified
- Mar 2018
- First submitted
- 1 Dec 2014
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Martin-Pelegrina MD, Lorenzo-Rodriguez A, Lora-Pablos D, Munoz-Amat B, Morales-Betancourt C, Pallas-Alonso CR. FiO2 control by parents of preterm infants admitted to a neonatal intensive care unit: A pilot study. Acta Paediatr. 2018 Aug;107(8):1471-1472. doi: 10.1111/apa.14364. Epub 2018 May 11. No abstract available.
PubMed 29676033
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Paradigm for Improving Neonatal Care: Clinical Study on Optimal Oxygen-saturation Time and the Adding Value of Parents to Nursing Care in the Control of Fi02
- ClinicalTrials.gov ID
- NCT02306317
- Acronym / sponsor ID
- Neonatología-2014-01
- Conditions
- Premature Birth of Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Carmen Rosa PallasUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- Mar 2014 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 3 Dec 2014 (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.
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. If the hypothesis of this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their children admitted in a neonatal intensive care unit.
Detailed description
Both episodes of hyperoxia and hypoxemia in preterm infants increase morbidity and mortality. Nowadays the adjustment of FiO2 is manually controlled, which means it depends on the staff, needing multiple adjustments throughout the day.
The investigators's hypothesis is that the FiO2 control by parents, improve the percentage of time in range of optimum saturation at least 10% compared to control by nurses.
The aim of this study is to compare the proportion of time with oxygen saturation (SpO2) within the assigned target range, in the preterm infants whose parents modify the fraction of inspired oxygen (FiO2) versus the nursing staff modifying group.
This is a randomized controlled clinical study in the neonatal intensive care unit at Hospital 12 de Octubre. Patients will be randomized in two groups, Experimental Group: parents controlling the saturation ranges, they will manually adjust FiO2 versus the Control Group: controlled by nursing staff (standard procedure). Saturations will be registered and adjustments of FiO2 will be filmed for nonconsecutive 20-hours periods. Twenty-three patients will be enrolled in each group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control by nursing. | Active comparator | Other: Standard procedureFiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure |
| Control by parents. | Experimental | Other: Experimental procedureFiO2 adjusted manually by parents. Intervention. Other. Experimental procedure |
Who may qualify
- Ages
- 7 days to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Related to child
- Preterm neonates less than 32 weeks or less than 1500 g hospitalized in the Neonatal Intensive Care Unit at Hospital 12 de Octubre.
- Receiving supplemental oxygen ≤0.4 administered by CPAP or conventional nasal cannula or high flow or children with BiPAP (flow generator with double level pressure)
- Minimum age 7 days old.
- Related to the mother:
Key exclusion criteria (3 listed)
- Evidence of pneumothorax or pneumomediastinum.
- Non-compliance with study protocol.
- Requiring treatment with vasoactive drugs.
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 |
|---|---|---|
| Standard procedureFiO2 manually controlled by nursing | Other | Control by nursing. |
| Experimental procedureFiO2 manually controlled by parents, after training. | Other | Control by parents. |
Primary outcome
Children maintained within the saturation ranges in each group
Time frame: 20-40 hours as maximum
Percentage of time the child is kept within the ranges of saturation in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Derived from this study: PubMed 29676033Martin-Pelegrina MD, Lorenzo-Rodriguez A, Lora-Pablos D, Munoz-Amat B, Morales-Betancourt C, Pallas-Alonso CR. FiO2 control by parents of preterm infants admitted to a neonatal intensive care unit: A pilot study. Acta Paediatr. 2018 Aug;107(8):1471-1472. doi: 10.1111/apa.14364. Epub 2018 May 11. No abstract available.
- 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.
Carmen R. Pallás Alonso, Dra. principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard procedure and Experimental procedure in people with Premature Birth of Newborn, run by Carmen Rosa Pallas at 1 site in Spain.
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 9 inclusion and 3 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 15 Mar 2018. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen R. Pallás Alonso, Dra. (34 913908272, carmenrosa.pallas@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children maintained within the saturation ranges in each group (time frame: 20-40 hours as maximum). 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 NCT02306317, which also lists 1 linked publication.
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 15 Mar 2018.