RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants

Investigating the Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants - A Randomised Controlled Trial

The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU. The main question it aims to answer is: 1) is there an optimal position for an infant to be held during KMC and 2) to optimise benefits for infants receiving KMC. Participants will be: 1) randomised into two groups which determine which angle they will start at first, 2) assessed over two hour-long sessions on different days with a change in the angle at the 30 minute point, 3) monitored using a Massimo NIRS machine which will record oxygen saturations, cerebral NIRS values and heart rates, and 4) monitored for any episodes of desaturations and bradycardias during this time. Participants will then be assessed beginning with the the other angle first on a different day. The researchers will then compare the two groups to see if being held at a 30 degrees during KMC is superior to being held at 60 degrees in terms of physiological stability.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Very Low Birth Weight Infant; Extreme Prematurity; Extremely Low Birth Weight
• Intervention / Treatment: Other: Held Position

Detailed Description

In this proposed study the investigators will examine whether there is an optimal position in which to perform KMC. This will be performed by evaluating cerebral oxygenation with near infrared spectroscopy (NIRS). Cerebral Near-Infrared Spectroscopy (NIRS) is used as a non-invasive assessment of cerebral oxygenation and cerebral hemodynamics. NIRS gives an estimation of the regional cerebral tissue oxygenation via a probe attached to the baby's forehead. It is minimally invasive and won't interrupt any of baby's cares or interrupt time with parents. The investigators will use NIRS to specifically examine whether there is a difference in physiological parameters between being held when the Mother/Father is at a 30 degree or 60 degree angle on the bedside recliner and whether better oxygenation is associated with one position over another. Currently there are no studies assessing the optimal position to carry out KMC in neonatal units. This study proposes to help answer a question which has not yet been answered in the literature.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Munster
    • Cork, Munster, Ireland
      • Cork University Maternity Hospital, Wilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ex-premature infants who are a minimum of 28 weeks corrected gestational age
• Minimum weight at assessment for entry to study 600g
• Signed informed consent form

Exclusion Criteria:

• Corrected gestational age under 28 weeks
• Known neurological anomalies (not intraventricular Haemorrhage)
• Known orthopaedic conditions
• Known chromosomal anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 30 degrees; Baby is held at 30 degrees during kangaroo mother care in the NICU	Other: Held Position; Change in angle of held position during kangaroo mother care to alternative angle
Active Comparator: 60 degrees; Baby is held at 60 degrees during kangaroo mother care in the NICU	Other: Held Position; Change in angle of held position during kangaroo mother care to alternative angle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean cerebral NIRS values over KMC session	Mean cerebral NIRS values over the KMC session at the two different angles	2 hours in total per infant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean peripheral saturation values over KMC session	Mean peripheral saturation values over the KMC session at the two different angles	2 hours
Mean heart rate values over KMC session	Mean heart rate values over the KMC session at the two different angles	2 hours
Number of bradycardias <100bpm over KMC session	Number of bradycardias <100bpm over the KMC session at the two different angles	2 hours
Number of Desaturations less than 80% for > 20 secs over KMC session	Number of Desaturations less than 80% for > 20 secs over KMC session at the two different angles	2 hours

Collaborators and Investigators

• Sponsor: University College Cork
• Collaborators: Cork University Maternity Hospital

Publications and helpful links

General Publications

• Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee. Kangaroo care for the preterm infant and family. Paediatr Child Health. 2012 Mar;17(3):141-6. doi: 10.1093/pch/17.3.141.
• Ludington-Hoe SM, Johnson MW, Morgan K, Lewis T, Gutman J, Wilson PD, Scher MS. Neurophysiologic assessment of neonatal sleep organization: preliminary results of a randomized, controlled trial of skin contact with preterm infants. Pediatrics. 2006 May;117(5):e909-23. doi: 10.1542/peds.2004-1422.
• Charpak N, Tessier R, Ruiz JG, Hernandez JT, Uriza F, Villegas J, Nadeau L, Mercier C, Maheu F, Marin J, Cortes D, Gallego JM, Maldonado D. Twenty-year Follow-up of Kangaroo Mother Care Versus Traditional Care. Pediatrics. 2017 Jan;139(1):e20162063. doi: 10.1542/peds.2016-2063. Epub 2016 Dec 12.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: NICU; Heart rate; NIRS; Oxygen saturation; Kangaroo Mother Care
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Body Weight; Birth Weight
• Other Study ID Numbers: 21121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No