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

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infant; Premature Birth; Extreme Prematurity; Extremely Low Birth Weight
• Interventions: Other: Held Position

• Registration Number: NCT05686252
• Lead Sponsor: University College Cork

Brief 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.

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 Timeline

• Study Start: 2022-05-16
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-16
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
30 degrees	Held Position	Baby is held at 30 degrees during kangaroo mother care in the NICU
60 degrees	Held Position	Baby is held at 60 degrees during kangaroo mother care in the NICU

Primary Outcome Measures

Name	Time	Method
Mean cerebral NIRS values over KMC session	2 hours in total per infant	Mean cerebral NIRS values over the KMC session at the two different angles

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cork University Maternity Hospital, Wilton; 🇮🇪 Cork, Munster, Ireland