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The Effect of Kangaroo Father Care Transport on Preterm Infants

NCT ID: NCT06725914

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-03

Study Completion Date

2024-12-24

Brief Summary

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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

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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

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Nurse's Role Preterm Birth Fathers

Keywords

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Father Early kangaroo care preterm infant nurse transport

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
In this study, statistician blinding was used for the implementation of randomization and data analysis.

Study Groups

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Implementation of paternal early kangaroo care transport

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.

Group Type EXPERIMENTAL

kangaroo care

Intervention Type BEHAVIORAL

Transport practice with paternal kangaroo care in preterm infants

Control Group

The babies in the control group were transported to the NICU in the arms of the nurse after birth as in the clinical routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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kangaroo care

Transport practice with paternal kangaroo care in preterm infants

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

34 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role collaborator

Zeynep Büşra GÜÇLÜ

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Büşra GÜÇLÜ

Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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SELÇUK University

Konya, Selçuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37884013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33118268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29224247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35039187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36811579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35010848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39024964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37454580 (View on PubMed)

Other Identifiers

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Selcuk University Health Care

Identifier Type: -

Identifier Source: org_study_id