ImmaturityNCT01865409
Effect of Kangaroo Care on Heart Rate Variability
A study testing Kangaroo Care in people with Immaturity and Oral Intolerance, run by Fatih University at 1 site in Turkey (Türkiye).
Trial summary
Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. Read more about this study
- Who is it for?
- Ages 32 to 35 weeks
- Conditions the study is for
- Immaturity, Oral Intolerance, Postnatal Adaptation
- What is being tested?
- Kangaroo Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Sep 2014
- 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 32 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants between 32 t0 35 weeks old
- After 7 days of extra-uterine life
Who cannot join
- Sepsis, infection
- Cardiac disease
- Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fatih University School of Medicine
Ankara, Ankara, 06590
Mehmet Kenan Kanburoglu, MD, +905326685916, madduckk@gmail.com
About this study
Official title: Does Kangaroo Care Effects on Heart Rate Variability in Neonates
Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.
- Conditions
- Immaturity, Oral Intolerance, Postnatal Adaptation
- Being tested
- Kangaroo Care
- Keywords
- Newborn, Prematures, Feeding difficulty, Kangaroo Care, Heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
Also called Kangaroo Mother Care, Skin to skin contact
Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult.
| Study group | Role | What they receive |
|---|---|---|
| Kangoroo care | Active comparator | While performing "Kangaroo care" the infant should be held skin-to-skin contact with her mother for 30-60 minutes. The baby, who is naked except for a diaper and a piece of cloth covering his or her back (either a receiving blanket or the parent's clothing), is placed in an upright position against a parent's bare chest. The values of heart rate variability will be measured during and also without Kangaroo Care in the same infants but different times. Receives: Behavioral: Kangaroo Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV-Sympathetic-Short Measurement-LF
By using Holter monitorization for 24 haur. LF (frequency domain, low frequency measurement): The low-frequency (LF) spectra represents predominantly sympathetic with some parasympathetic influence in the 0.04-to-0.15 Hz range.
Measured: 5 Minutes
Secondary outcomes (1)
Time Domain Measurements of HRV
By using Holter monitorization for 24 haur, 5 different measurements get by 5 minutes heart rate analysis: SDNN, SDANN,SDNN index,Rmssd,pNN50 SDNN: ms, Standard deviation of all NN intervals. SDANN: ms Standard deviation of the averages of NN intervals in all 5 min segments of the entire recording.
SDNN index: ms, mean of the standard deviations of all NN intervals for all 5 min segments of the entire recording RMSSD: ms, The square root of the mean of the sum of the squares of diVerences between adjacent NN intervals.
pNN50: % NN50 count divided by the total number of all NN intervals
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ImmaturityStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kenan Kanburoglu, Fatih University
- Investigators
- Mehmet Kenan Kanburoglu, MD, Study director, NeonatologistMehmet Nevzat Cizmeci, MD, Principal investigator, NeonatologistMustafa Mansur Tatli, MD, Prof, Study chair, Neonatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865409
- Sponsor's protocol ID
- B 30 FTH 0 20 00 00 / 1503
- Status last verified
- Sep 2014
- First submitted
- 27 May 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Srinivasan L, Harris MC. New technologies for the rapid diagnosis of neonatal sepsis. Curr Opin Pediatr. 2012 Apr;24(2):165-71. doi: 10.1097/MOP.0b013e3283504df3.
PubMed 22273634Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Harrison TM. Trajectories of parasympathetic nervous system function before, during, and after feeding in infants with transposition of the great arteries. Nurs Res. 2011 May-Jun;60(3 Suppl):S15-27. doi: 10.1097/NNR.0b013e31821600b1.
PubMed 21543958
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Kangaroo Care Effects on Heart Rate Variability in Neonates
- ClinicalTrials.gov ID
- NCT01865409
- Acronym / sponsor ID
- B 30 FTH 0 20 00 00 / 1503
- Conditions
- Immaturity, Oral Intolerance, Postnatal Adaptation
- Keywords
- Newborn, Prematures, Feeding difficulty, Kangaroo Care, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fatih UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 30 May 2013 (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.
Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kangoroo care | Active comparator | Behavioral: Kangaroo CareWhile performing "Kangaroo care" the infant should be held skin-to-skin contact with her mother for 30-60 minutes. The baby, who is naked except for a diaper and a piece of cloth covering his or her back (either a receiving blanket or the parent's clothing), is placed in an upright position against a parent's bare chest. The values of heart rate variability will be measured during and also without Kangaroo Care in the same infants but different times. |
Who may qualify
- Ages
- 32 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature infants between 32 t0 35 weeks old
- After 7 days of extra-uterine life
Key exclusion criteria (3 listed)
- Sepsis, infection
- Cardiac disease
- Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis
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 |
|---|---|---|
| Kangaroo CareAlso: Kangaroo Mother Care, Skin to skin contactKangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult. | Behavioural | Kangoroo care |
Primary outcome
HRV-Sympathetic-Short Measurement-LF
Time frame: 5 Minutes
By using Holter monitorization for 24 haur. LF (frequency domain, low frequency measurement): The low-frequency (LF) spectra represents predominantly sympathetic with some parasympathetic influence in the 0.04-to-0.15 Hz range.
1 secondary outcome
Time Domain Measurements of HRV
Time frame: 5 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Background: PubMed 22273634Srinivasan L, Harris MC. New technologies for the rapid diagnosis of neonatal sepsis. Curr Opin Pediatr. 2012 Apr;24(2):165-71. doi: 10.1097/MOP.0b013e3283504df3.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 21543958Harrison TM. Trajectories of parasympathetic nervous system function before, during, and after feeding in infants with transposition of the great arteries. Nurs Res. 2011 May-Jun;60(3 Suppl):S15-27. doi: 10.1097/NNR.0b013e31821600b1.
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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.
Mehmet Kenan Kanburoglu, MD study director
Neonatologist
Mehmet Nevzat Cizmeci, MD principal investigator
Neonatologist
Mustafa Mansur Tatli, MD, Prof study chair
Neonatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care in people with Immaturity and Oral Intolerance, run by Fatih 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 2 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 9 Sep 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Kenan Kanburoglu, MD (+905326685916, madduckk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRV-Sympathetic-Short Measurement-LF (time frame: 5 Minutes). 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 NCT01865409, which also lists 3 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 9 Sep 2014.