Nurse's RoleNCT06725914
The Effect of Kangaroo Father Care Transport on Preterm Infants
A study testing kangaroo care in people with Nurse's Role and Preterm Birth, run by Zeynep Büşra GÜÇLÜ at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Preterm Birth, Fathers
- 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2023to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born by caesarean section,
- Born at 34-36+6 weeks gestation,
- Apgar score of 7 and above at 1 and 5 minutes,
- Stable and healthy,
- Infants with a body weight of 1500 g and above were included. It's about the father;
- Who volunteered to participate in the study,
Show all 9Show fewer
- No mental and psychological problems,
- No communication problems (speech, hearing and severe visual impairment),
- Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.
Who cannot join
- Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
- Receiving invasive and noninvasive respiratory support,
- With chest tube and umbilical catheter,
- Foreign babies and their fathers were ostracized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study
This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.
Read the detailed description
This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.
- Conditions
- Nurse's Role, Preterm Birth, Fathers
- Being tested
- kangaroo care
- Keywords
- Father, Early kangaroo care, preterm infant, nurse, transport
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kangaroo careBehavioural
Transport practice with paternal kangaroo care in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| Implementation of paternal early kangaroo care transport | Experimental | Early kangaroo care was administered immediately after delivery. The fathers were seated on a wheelchair for transportation from the gynecology operating room to the NICU. The newborn was then dressed in a diaper and hat. The preterm baby was laid naked on the father's bare chest in an upright position. Preterms were secured with a kangaroo care garment in the frog leg position in the prone position with the head turned to the side. The baby was covered with a blanket to prevent heat loss. Receives: Behavioral: kangaroo care |
| Control Group | No intervention | The babies in the control group were transported to the NICU in the arms of the nurse after birth as in the clinical routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Parameter Monitoring Form-Heart Rate
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Measured: 3 minutes before the intervention
Physiological Parameter Monitoring Form-SPO2
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Measured: 3 minutes before the intervention
Physiological Parameter Monitoring Form-Body temperature (°C)
Body temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Measured: 3 minutes before the intervention
Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics
Paternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.
Measured: 15 minutes before the intervention
State Anxiety Scale
State Anxiety Scale was recorded 15 minutes before the intervention.
Measured: 15 minutes before the intervention
Father-Infant Attachment Scale
Father-Infant Attachment Scale was recorded 15 minutes before the intervention.
Measured: 15 minutes before the intervention
Secondary outcomes (8)
Physiological Parameter Monitoring Form-Heart Rate
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
Measured: 3 minutes after the end of kangaroo care (T2).
Physiological Parameter Monitoring Form-Heart Rate
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
Measured: 3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-SPO2
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
Measured: 3 minutes after initiation of transport with kangaroo care.(T1)
Fizyolojik Parametre İzleme Formu-SPO2
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
Measured: 3 minutes after the end of kangaroo care (T2)
Physiological Parameter Monitoring Form-Body temperature (℃)
Body temperature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
Measured: 3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-Body temparature (℃)
Body temparature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
Measured: 3 minutes after the end of kangaroo care (T2).
State Anxiety Scale
State Anxiety Scale 15 minutes after the end of the intervention (T2)
Measured: 15 minutes before the intervention (T2)
Father-Infant Attachment Scale
Father-Infant Attachment Scale was recorded 15 minutes after the intervention.
Measured: 15 minutes after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start3 Dec 2023
- Primary completion16 Jun 2024
- Study completion24 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a single-blind, parallel group, randomized controlled experimental design.Randomization was performed by an independent investigator to avoid bias. Preterm infants were randomly assigned to the experimental and control groups (1:1) by simple randomization method. Using the permutation block randomization method, 6 permutations were formed as a block of 4 using the letters A and B. The number of samples was divided by the number of permutations (40/6=7) and sorted 7 times from 1 to 6 using a table of random numbers (www.randomizer.org). The combinations generated according to this order (e.g. BBAA (3) ABBA (2)) were prepared in sealed envelopes (40 pieces) by an independent statistician. Which letter represented which group was determined by lottery. To ensure confidentiality, each preterm infant was randomly assigned a numerical code and the results were reported to the researcher collectively in sealed opaque envelopes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Büşra GÜÇLÜ
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor-investigator, Zeynep Büşra GÜÇLÜ, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725914
- Sponsor's protocol ID
- Selcuk University Health Care
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Yildirim F, Buyukkayaci Duman N, Sahin E, Vural G. The Effect of Kangaroo Care on Paternal Attachment: A Randomized Controlled Study. Adv Neonatal Care. 2023 Dec 1;23(6):596-601. doi: 10.1097/ANC.0000000000001100. Epub 2023 Oct 26.
PubMed 37884013Unal Toprak F, Senturk Erenel A. Impact of kangaroo care after caesarean section on paternal-infant attachment and involvement at 12 months: A longitudinal study in Turkey. Health Soc Care Community. 2021 Sep;29(5):1502-1510. doi: 10.1111/hsc.13210. Epub 2020 Oct 28.
PubMed 33118268Varela N, Tessier R, Tarabulsy G, Pierce T. Cortisol and blood pressure levels decreased in fathers during the first hour of skin-to-skin contact with their premature babies. Acta Paediatr. 2018 Apr;107(4):628-632. doi: 10.1111/apa.14184. Epub 2017 Dec 29.
PubMed 29224247Bodet LM, Danielo M, Roze JC, Flamant C, Muller JB. Father newborn skin-to-skin wheelchair transfer from delivery room to neonatal care unit: Possible change in practices. Arch Pediatr. 2022 Feb;29(2):100-104. doi: 10.1016/j.arcped.2021.11.005. Epub 2022 Jan 14.
PubMed 35039187Pujara RK, Upadhyay V, Thacker JP, Rana BB, Patel SS, Joshi JM, Shinde MK, Nimbalkar SM, Patel DV. Efficacy of skin-to-skin vs. cloth-to-cloth contact for thermoregulation in low birth weight newborns: a randomized crossover trial. J Trop Pediatr. 2023 Feb 6;69(2):fmad013. doi: 10.1093/tropej/fmad013.
PubMed 36811579Cristobal Canadas D, Bonillo Perales A, Galera Martinez R, Casado-Belmonte MDP, Parron Carreno T. Effects of Kangaroo Mother Care in the NICU on the Physiological Stress Parameters of Premature Infants: A Meta-Analysis of RCTs. Int J Environ Res Public Health. 2022 Jan 5;19(1):583. doi: 10.3390/ijerph19010583.
PubMed 35010848Tas Arslan F, Akkoyun S, Kucukoglu S, Kocoglu-Tanyer D, Konak M, Soylu H. Effect of kangaroo mother care on cerebral oxygenation, physiological parameters, and comfort levels in late-premature infants: A randomized controlled trial. Midwifery. 2024 Oct;137:104096. doi: 10.1016/j.midw.2024.104096. Epub 2024 Jul 7.
PubMed 39024964Durmaz A, Sezici E, Akkaya DD. The effect of kangaroo mother care or skin-to-skin contact on infant vital signs: A systematic review and meta-analysis. Midwifery. 2023 Oct;125:103771. doi: 10.1016/j.midw.2023.103771. Epub 2023 Jul 10.
PubMed 37454580
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06725914
- Acronym / sponsor ID
- Selcuk University Health Care
- Conditions
- Nurse's Role, Preterm Birth, Fathers
- Keywords
- Father, Early kangaroo care, preterm infant, nurse, transport
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zeynep Büşra GÜÇLÜUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 24 Dec 2024 (estimated)
- First posted
- 10 Dec 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.
This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.
Detailed description
This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a single-blind, parallel group, randomized controlled experimental design.Randomization was performed by an independent investigator to avoid bias. Preterm infants were randomly assigned to the experimental and control groups (1:1) by simple randomization method. Using the permutation block randomization method, 6 permutations were formed as a block of 4 using the letters A and B. The number of samples was divided by the number of permutations (40/6=7) and sorted 7 times from 1 to 6 using a table of random numbers (www.randomizer.org). The combinations generated according to this order (e.g. BBAA (3) ABBA (2)) were prepared in sealed envelopes (40 pieces) by an independent statistician. Which letter represented which group was determined by lottery. To ensure confidentiality, each preterm infant was randomly assigned a numerical code and the results were reported to the researcher collectively in sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Implementation of paternal early kangaroo care transport | Experimental | Behavioral: kangaroo careEarly kangaroo care was administered immediately after delivery. The fathers were seated on a wheelchair for transportation from the gynecology operating room to the NICU. The newborn was then dressed in a diaper and hat. The preterm baby was laid naked on the father's bare chest in an upright position. Preterms were secured with a kangaroo care garment in the frog leg position in the prone position with the head turned to the side. The baby was covered with a blanket to prevent heat loss. |
| Control Group | No intervention | –The babies in the control group were transported to the NICU in the arms of the nurse after birth as in the clinical routine. |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Born by caesarean section,
- Born at 34-36+6 weeks gestation,
- Apgar score of 7 and above at 1 and 5 minutes,
- Stable and healthy,
- Infants with a body weight of 1500 g and above were included. It's about the father;
Key exclusion criteria (4 listed)
- Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
- Receiving invasive and noninvasive respiratory support,
- With chest tube and umbilical catheter,
- Foreign babies and their fathers were ostracized.
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 careTransport practice with paternal kangaroo care in preterm infants | Behavioural | Implementation of paternal early kangaroo care transport |
Primary outcome
Physiological Parameter Monitoring Form-Heart Rate
Time frame: 3 minutes before the intervention
Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Physiological Parameter Monitoring Form-SPO2
Time frame: 3 minutes before the intervention
SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Physiological Parameter Monitoring Form-Body temperature (°C)
Time frame: 3 minutes before the intervention
Body temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics
Time frame: 15 minutes before the intervention
Paternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.
State Anxiety Scale
Time frame: 15 minutes before the intervention
State Anxiety Scale was recorded 15 minutes before the intervention.
Father-Infant Attachment Scale
Time frame: 15 minutes before the intervention
Father-Infant Attachment Scale was recorded 15 minutes before the intervention.
8 secondary outcomes
Physiological Parameter Monitoring Form-Heart Rate
Time frame: 3 minutes after the end of kangaroo care (T2).
Physiological Parameter Monitoring Form-Heart Rate
Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-SPO2
Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)
Fizyolojik Parametre İzleme Formu-SPO2
Time frame: 3 minutes after the end of kangaroo care (T2)
Physiological Parameter Monitoring Form-Body temperature (℃)
Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)
Physiological Parameter Monitoring Form-Body temparature (℃)
Time frame: 3 minutes after the end of kangaroo care (T2).
State Anxiety Scale
Time frame: 15 minutes before the intervention (T2)
Father-Infant Attachment Scale
Time frame: 15 minutes after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 37884013Yildirim F, Buyukkayaci Duman N, Sahin E, Vural G. The Effect of Kangaroo Care on Paternal Attachment: A Randomized Controlled Study. Adv Neonatal Care. 2023 Dec 1;23(6):596-601. doi: 10.1097/ANC.0000000000001100. Epub 2023 Oct 26.
- Background: PubMed 33118268Unal Toprak F, Senturk Erenel A. Impact of kangaroo care after caesarean section on paternal-infant attachment and involvement at 12 months: A longitudinal study in Turkey. Health Soc Care Community. 2021 Sep;29(5):1502-1510. doi: 10.1111/hsc.13210. Epub 2020 Oct 28.
- Background: PubMed 29224247Varela N, Tessier R, Tarabulsy G, Pierce T. Cortisol and blood pressure levels decreased in fathers during the first hour of skin-to-skin contact with their premature babies. Acta Paediatr. 2018 Apr;107(4):628-632. doi: 10.1111/apa.14184. Epub 2017 Dec 29.
- Background: PubMed 35039187Bodet LM, Danielo M, Roze JC, Flamant C, Muller JB. Father newborn skin-to-skin wheelchair transfer from delivery room to neonatal care unit: Possible change in practices. Arch Pediatr. 2022 Feb;29(2):100-104. doi: 10.1016/j.arcped.2021.11.005. Epub 2022 Jan 14.
- Background: PubMed 36811579Pujara RK, Upadhyay V, Thacker JP, Rana BB, Patel SS, Joshi JM, Shinde MK, Nimbalkar SM, Patel DV. Efficacy of skin-to-skin vs. cloth-to-cloth contact for thermoregulation in low birth weight newborns: a randomized crossover trial. J Trop Pediatr. 2023 Feb 6;69(2):fmad013. doi: 10.1093/tropej/fmad013.
- Background: PubMed 35010848Cristobal Canadas D, Bonillo Perales A, Galera Martinez R, Casado-Belmonte MDP, Parron Carreno T. Effects of Kangaroo Mother Care in the NICU on the Physiological Stress Parameters of Premature Infants: A Meta-Analysis of RCTs. Int J Environ Res Public Health. 2022 Jan 5;19(1):583. doi: 10.3390/ijerph19010583.
- Background: PubMed 39024964Tas Arslan F, Akkoyun S, Kucukoglu S, Kocoglu-Tanyer D, Konak M, Soylu H. Effect of kangaroo mother care on cerebral oxygenation, physiological parameters, and comfort levels in late-premature infants: A randomized controlled trial. Midwifery. 2024 Oct;137:104096. doi: 10.1016/j.midw.2024.104096. Epub 2024 Jul 7.
- Background: PubMed 37454580Durmaz A, Sezici E, Akkaya DD. The effect of kangaroo mother care or skin-to-skin contact on infant vital signs: A systematic review and meta-analysis. Midwifery. 2023 Oct;125:103771. doi: 10.1016/j.midw.2023.103771. Epub 2023 Jul 10.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nurse's Role and Preterm Birth, run by Zeynep Büşra GÜÇLÜ 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 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Physiological Parameter Monitoring Form-Heart Rate (time frame: 3 minutes before the intervention). The study lists 6 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 NCT06725914, which also lists 8 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 10 Dec 2024.