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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686252
• Other study ID #: 21121
• Status: Completed
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Extreme Prematurity
• Extremely Low Birth Weight
• Premature Birth
• Very Low Birth Weight Infant

Intervention

Other:
• Held Position
Change in angle of held position during kangaroo mother care to alternative angle

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital, Wilton	Cork	Munster

Sponsors (2)

Lead Sponsor	Collaborator
University College Cork	Cork University Maternity Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean peripheral saturation values over KMC session	Mean peripheral saturation values over the KMC session at the two different angles	2 hours
Secondary	Mean heart rate values over KMC session	Mean heart rate values over the KMC session at the two different angles	2 hours
Secondary	Number of bradycardias <100bpm over KMC session	Number of bradycardias <100bpm over the KMC session at the two different angles	2 hours
Secondary	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