Clinical trial NCT06725914: The Effect of Kangaroo Father Care Transport on Preterm Infants
Official title: The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nurse's Role
Preterm Birth
Fathers
Keywords: Father
Early kangaroo care
preterm infant
nurse
transport
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Selcuk University
First posted: 2024-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:Neonatal related;

* 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,
* 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.

Exclusion Criteria:- Congenital anomalies,

* 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.

Primary outcomes:
measure: Physiological Parameter Monitoring Form-Heart Rate
timeFrame: 3 minutes before the intervention
measure: Physiological Parameter Monitoring Form-SPO2
timeFrame: 3 minutes before the intervention
measure: Physiological Parameter Monitoring Form-Body temperature (°C)
timeFrame: 3 minutes before the intervention
measure: Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics
timeFrame: 15 minutes before the intervention
measure: State Anxiety Scale
timeFrame: 15 minutes before the intervention
measure: Father-Infant Attachment Scale
timeFrame: 15 minutes before the intervention
Secondary outcomes:
measure: Physiological Parameter Monitoring Form-Heart Rate
timeFrame: 3 minutes after the end of kangaroo care (T2).
measure: Physiological Parameter Monitoring Form-Heart Rate
timeFrame: 3 minutes after initiation of transport with kangaroo care.(T1)
measure: Physiological Parameter Monitoring Form-SPO2
timeFrame: 3 minutes after initiation of transport with kangaroo care.(T1)
measure: Fizyolojik Parametre İzleme Formu-SPO2
timeFrame: 3 minutes after the end of kangaroo care (T2)
measure: Physiological Parameter Monitoring Form-Body temperature (℃)
timeFrame: 3 minutes after initiation of transport with kangaroo care.(T1)
measure: Physiological Parameter Monitoring Form-Body temparature (℃)
timeFrame: 3 minutes after the end of kangaroo care (T2).
measure: State Anxiety Scale
timeFrame: 15 minutes before the intervention (T2)
measure: Father-Infant Attachment Scale
timeFrame: 15 minutes after the intervention.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: SELÇUK University
state: Selçuklu
Study officials:
References:
citation: 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.
citation: Unal 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.
citation: Varela 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.
citation: Bodet 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.
citation: Pujara 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.
citation: Cristobal 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.
citation: Tas 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.
citation: Durmaz 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.