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Comparison of two positions of Kangaroo mother care for its effect on heart rate and oxygen saturation in small preterm babies.

Effect of Modified Kangaroo Mother Care Position in Preterm Newborns with Apnea of Prematurity: A Randomised Crossover Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/109946
Enrollment
30
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P284- Other apnea of newborn

Interventions

Intervention1: Modified KMC (nested lateral vertical) position: The premature newborn will stay in between the mother s breasts in the upright position and side-lying, providing maximal skin-to-skin c

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm newborns with a birth weight of less than 1250 grams with a clinical diagnosis of apnea of prematurity, or apnea bradycardia episodes or intermittent hypoxia episodes will be enrolled. 2. Preterm newborn who demonstrate poor saturation histogram profile will also be enrolled.

Exclusion criteria

Exclusion criteria: 1. Antenatally diagnosed major congenital anomalies or chromosomal disorders or major surgical conditions. 2. Antenatal diagnosis of conditions resulting in poor prognosis. 3. Hemodynamically unstable newborns

Design outcomes

Primary

MeasureTime frame
Primary objective is to compare the event rates in preterm newborns with birth weight less than 1250 grams, during nested lateral vertical KMC position vs standard prone vertical KMC position for: 1. Proportion of time with preductal SpO2 less than 90% during the KMC session. 2. Proportion of time with HR less than 100/min during the KMC session. 3. KMC session interruption for desaturations/prolonged apnea/bradycardia for non-improvement in vitals and requiring resuscitation.Timepoint: Pulse oximeter readings during KMC sessions for 2 hours

Secondary

MeasureTime frame
1. Proportion of time heart rate less than 80/min on histogram analysis. 2. Proportion of time preductal saturation will be less than 85 on saturation histogram analysis. 3. Pain scores as assessed by Premature infant pain profile at 15 minutes interval during the KMC session. 4. Apnea- bradycardia episodes while on KMC session. 5. Percentage changes in FiO2 from baseline and maximal Fio2. 6. Surface temperature recordings during the session on a predesignated site. Subgroup analysis will be comparisons of time spent in desaturation (less than 90%), stratified across different 1. Postmenstrual age (PMA) groups 2. Types of respiratory support.Timepoint: 1. Pulse oximeter readings for Heart rate, Preductal Saturation during KMC sessions for 2 hours 2. Pain profile at 15, 30, 45, 60, 75, 90, 105, 120 mins during KMC session 3. Surface temperature recordings during KMC sessions for 2 hours

Countries

India

Contacts

Public ContactDr Chetan Khare

AIIMS Bhopal

drchetankhare@gmail.com9843395041

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026