Skin-to-skin Contact Between Premature Infant and Mother

NCT06380231 | Completed

• 1 other identifier: IRU-YAZILE-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days.

Conditions

Kangaroo-mother Care

Keywords

premature; kangaroo mother care; heart rate; oxygen saturation; perfusion index

Outcome Measures

Primary Outcomes (1)

• power analysis

  For the sample size, we considered Cohen "s effect size (d) value, which is the acceptable limit in the field of health sciences. The sample size was calculated by a t-test in the G\*Power 3.1.7 program.

  two months

Secondary Outcomes (1)

• The effect of kangaroo mother care

  Examined physiological parameters of both groups were measured before, during and after KMC and traditional mother's bosom . This measurement was made at 15-minute intervals for 45 minutes (0-01th,15th,30th,45 th minutes)

Study Arms (2)

kangaroo mother care (KMC) for experimental group

EXPERIMENTAL

Examined physiological parameters of both groups were measured before, during and after KMC and traditional mother's bosom. This measurement was made at 15-minute intervals for 45 minutes (0-01,15,30,45 minutes). Physiological parameters before and after KMC and traditional mother's bosom represent incubator conditions.

Other: kangaroo mother care (KMC)

control group

NO INTERVENTION

The control group received only traditional mother's bosom. In the control group, unlike the experimental group, the mother's clothes were not removed. The hands of the mothers were cleaned with 0.4% chlorhexidine, and the mothers were seated in the KMC chair. The same chair was used for the experimental and control groups. A hospital shirt was placed over the mother's own clothes for hygiene purposes only. The baby was not naked, was given to his mother wrapped in a blanket. The infant spent 45 minutes in traditional mother's bosom without skin-to-skin contact. There were no restrictions placed on the position of the mother holding the infant, and she could hold the infant upright, horizontally, and to the right or left. In control groups, all mothers were permitted to sing lullabies or talk to their infants if they chose to do so.

Interventions

kangaroo mother care (KMC) OTHER

Kangaroo mother care is a simple care that aims to protect the health and well-being of premature babies, where skin-to-skin contact is achieved by placing the premature baby in an upright position, face down, between the parent's breasts, wearing only a diaper and a cap. Before the experimental group infant was given to the mother, his/her hat was put on, and clothes were removed. The infant was placed in an upright position (approximately 60°) between the mother's two breasts. To enable the infant to breathe, his/her head was positioned to the right or left with ear touching the mother's chest, arms and legs were flexed, and hip was abducted. The mother supported the infant's neck and back with one hand and the hips with the other. The infant's back was covered with a cotton blanket. An noninvasive pulse Co-oximetry was attached to the right wrist of the infant to evaluate heart rate, oxygen saturation, and perfusion index.

kangaroo mother care (KMC) for experimental group

Eligibility Criteria

• Age: 24 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

TC Istanbul Rumeli University

Istanbul, Haliç, 34445, Turkey (Türkiye)

Location

Related Publications (10)

• George, D., & Mallery, M. (2010).SPSS for windows step by step: A simple guide and reference, 17.0 update (10a ed.) Boston: Pearson

  BACKGROUND

• Karaagaoglu, E. (2013). An experimental design technique: Randomized block design. Turkish Journal of Biochemistry, 38 (1): 1-4

  BACKGROUND

• Nyqvist KH; Expert Group of the International Network on Kangaroo Mother Care; Anderson GC, Bergman N, Cattaneo A, Charpak N, Davanzo R, Ewald U, Ludington-Hoe S, Mendoza S, Pallas-Allonso C, Pelaez JG, Sizun J, Widstrom AM. State of the art and recommendations. Kangaroo mother care: application in a high-tech environment. Acta Paediatr. 2010 Jun;99(6):812-9. doi: 10.1111/j.1651-2227.2010.01794.x. Epub 2010 Mar 8.

  PMID: 20219028 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

• Kommers DR, Joshi R, van Pul C, Atallah L, Feijs L, Oei G, Bambang Oetomo S, Andriessen P. Features of Heart Rate Variability Capture Regulatory Changes During Kangaroo Care in Preterm Infants. J Pediatr. 2017 Mar;182:92-98.e1. doi: 10.1016/j.jpeds.2016.11.059. Epub 2016 Dec 15.

  PMID: 27989406 BACKGROUND

• Lee J, Parikka V, Lehtonen L, Soukka H. Parent-infant skin-to-skin contact reduces the electrical activity of the diaphragm and stabilizes respiratory function in preterm infants. Pediatr Res. 2022 Apr;91(5):1163-1167. doi: 10.1038/s41390-021-01607-2. Epub 2021 Jun 4.

  PMID: 34088986 BACKGROUND

• Pados BF, Hess F. Systematic Review of the Effects of Skin-to-Skin Care on Short-Term Physiologic Stress Outcomes in Preterm Infants in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2020 Feb;20(1):48-58. doi: 10.1097/ANC.0000000000000596.

  PMID: 30893092 BACKGROUND

• Jamal, A.Z., & John, B.M. (2020). Efficacy of noninvasive hemoglobin measurement by pulse co-oximetry in neonates. J Clin Neonatol., 9:57-62. Doi 10.4103/jcn.JCN_89_19

  BACKGROUND

• Nicholas C, George R, Sardesai S, Durand M, Ramanathan R, Cayabyab R. Validation of noninvasive hemoglobin measurement by pulse co-oximeter in newborn infants. J Perinatol. 2015 Aug;35(8):617-20. doi: 10.1038/jp.2015.12. Epub 2015 Mar 5.

  PMID: 25742288 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: April 23, 2024
• Study Start: November 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

TU (1)