The Effect of Kangaroo Father Care Transport on Preterm Infants

NCT06725914 | Active Not Recruiting

• 1 other identifier: Selcuk University Health Care
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role; Preterm Birth; Fathers

Keywords

Father; Early kangaroo care; preterm infant; nurse; transport

Outcome Measures

Primary Outcomes (6)

• Physiological Parameter Monitoring Form-Heart Rate

  Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

  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.

  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.

  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.

  15 minutes before the intervention

• State Anxiety Scale

  State Anxiety Scale was recorded 15 minutes before the intervention.

  15 minutes before the intervention

• Father-Infant Attachment Scale

  Father-Infant Attachment Scale was recorded 15 minutes before the intervention.

  15 minutes before the intervention

Secondary Outcomes (8)

• Physiological Parameter Monitoring Form-Heart Rate

  3 minutes after the end of kangaroo care (T2).

• Physiological Parameter Monitoring Form-Heart Rate

  3 minutes after initiation of transport with kangaroo care.(T1)

• Physiological Parameter Monitoring Form-SPO2

  3 minutes after initiation of transport with kangaroo care.(T1)

• Fizyolojik Parametre İzleme Formu-SPO2

  3 minutes after the end of kangaroo care (T2)

• Physiological Parameter Monitoring Form-Body temperature (℃)

  3 minutes after initiation of transport with kangaroo care.(T1)

Study Arms (2)

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.

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.

Interventions

kangaroo care BEHAVIORAL

Transport practice with paternal kangaroo care in preterm infants

Implementation of paternal early kangaroo care transport

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeynep Büşra GÜÇLÜ: lead
• Selcuk University: collaborator

Study Sites (1)

SELÇUK University

Konya, Selçuklu, 42000, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 37884013 BACKGROUND

• 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.

  PMID: 33118268 BACKGROUND

• 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.

  PMID: 29224247 BACKGROUND

• 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.

  PMID: 35039187 BACKGROUND

• 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.

  PMID: 36811579 BACKGROUND

• 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.

  PMID: 35010848 BACKGROUND

• 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.

  PMID: 39024964 BACKGROUND

• 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.

  PMID: 37454580 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, statistician blinding was used for the implementation of randomization and data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 10, 2024
• Study Start: December 3, 2023
• Primary Completion: June 16, 2024
• Study Completion: December 24, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)