Newborn PretermNCT02707731
Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
A study testing Hydrokinesiotherapy in people with Newborn Preterm, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before… Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Newborn Preterm
- What is being tested?
- Hydrokinesiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Nov 2015
- 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 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age above 37 weeks
- clinically stable
- without ventilatory support
Who cannot join
- access deep below the shoulders
- umbilical catheterization
- neurological and cardiac disorders
- clinically unstable
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.
Read the detailed description
Newborns have the neurological maturity to perceive pain, including preterm. In the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. Based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.
- Conditions
- Newborn Preterm
- Being tested
- Hydrokinesiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrokinesiotherapyProcedure or surgery
physical therapy technique used in a plastic bucket approved by ANVISA , with water temperature monitored at 37 ° C, water level up to the shoulders and by the physical properties of water, was allowed to mobilize the newborn facilitating the feeling of relaxation and standard suitable movement.
| Study group | Role | What they receive |
|---|---|---|
| Hydrokinesiotherapy in preterm | Experimental | Salivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy Receives: Procedure: Hydrokinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Measured: 4 months
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Measured: 4 months
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Measured: 4 months
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Measured: 4 months
Secondary outcomes (1)
Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionNov 2015
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 Newborn PretermStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Welcy Cassiano de Oliveira Tobinaga, Hospital Universitario Pedro Ernesto
- Investigators
- Welcy Cassiano Tobinaga, Student, Principal investigator, University Hospital Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707731
- Sponsor's protocol ID
- HUPedroernesto
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Oliveira Tobinaga WC, de Lima Marinho C, Abelenda VL, de Sa PM, Lopes AJ. Short-Term Effects of Hydrokinesiotherapy in Hospitalized Preterm Newborns. Rehabil Res Pract. 2016;2016:9285056. doi: 10.1155/2016/9285056. Epub 2016 Sep 8.
PubMed 27672453
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
- ClinicalTrials.gov ID
- NCT02707731
- Acronym / sponsor ID
- HUPedroernesto
- Conditions
- Newborn Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.
Detailed description
Newborns have the neurological maturity to perceive pain, including preterm. In the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. Based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrokinesiotherapy in preterm | Experimental | Procedure: HydrokinesiotherapySalivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age above 37 weeks
- clinically stable
- without ventilatory support
Key exclusion criteria (4 listed)
- access deep below the shoulders
- umbilical catheterization
- neurological and cardiac disorders
- clinically unstable
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 |
|---|---|---|
| Hydrokinesiotherapyphysical therapy technique used in a plastic bucket approved by ANVISA , with water temperature monitored at 37 ° C, water level up to the shoulders and by the physical properties of water, was allowed to mobilize the newborn facilitating the feeling of relaxation and standard suitable movement. | Procedure or surgery | Hydrokinesiotherapy in preterm |
Primary outcome
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Time frame: 4 months
Unrecognized Condition
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Time frame: 4 months
Unrecognized Condition
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Time frame: 4 months
Unrecognized Condition
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Time frame: 4 months
Unrecognized Condition
1 secondary outcome
Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
Time frame: 4 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 14 Mar 2016.
- Derived from this study: PubMed 27672453de Oliveira Tobinaga WC, de Lima Marinho C, Abelenda VL, de Sa PM, Lopes AJ. Short-Term Effects of Hydrokinesiotherapy in Hospitalized Preterm Newborns. Rehabil Res Pract. 2016;2016:9285056. doi: 10.1155/2016/9285056. Epub 2016 Sep 8.
- Individual participant dataSharing planned: No
Related trials for Newborn Preterm
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NEC - Necrotizing Enterocolitis
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Growing Little PEAPODS Study
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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.
Welcy Cassiano Tobinaga, Student principal investigator
University Hospital Pedro Ernesto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrokinesiotherapy in people with Newborn Preterm, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 3 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 14 Mar 2016. 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 Brazil. 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?
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized (time frame: 4 months). 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 NCT02707731, 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 14 Mar 2016.