Lung Ultrasound changes in newborns with respiratory distress during provision of CPAP while providing Kangaroo care

Comparing Lung Ultrasound (LUS) outcomes in preterm neonates (28 to 36 weeks gestation) on CPAP with and without KMC: A Randomized controlled trial - KULC Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101340

Enrollment

150

Registered

2026-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

Intervention1: Kangaroo Mother care on newborns with CPAP with severity being graded with lung ultrasound score and be comparared.: The babies who are having respiratory distress requiring CPAP soon a

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with gestational age between 28+0 and 36 weeks. Requiring CPAP support (initiated in first 24 hours of life) for respiratory distress per unit protocols. Clinically stable on CPAP defined as: FiO2 less than 0.40, CPAP pressures less than 7 cm H2O, haemodynamically stable (no inotropic support), and no urgent need for intubation at randomization. Parent/guardian able and willing to provide informed consent and to participate in KMC sessions. Birth weight more than 900 gm to less than 2.0 kg.

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies, including significant congenital lung, cardiac or neurological malformations. 2. Need for immediate intubation or mechanical ventilation at screening. 3. Severe cardiorespiratory instability (requiring inotropes, recurrent severe apnea requiring bag-mask ventilation) at screening 4. Skin conditions or maternal conditions preventing safe KMC (e.g., infectious contraindication in mother).

Design outcomes

Primary

Measure	Time frame
compare the change in Lung Ultrasound (LUS) score from baseline (within 6 hours of starting CPAP) to 48 hours in preterm neonates randomized to KMC during CPAP versus standard care (CPAP without KMC).Timepoint: 4 hours after intervention starting, then 8 hours and then 12 hours	—

Secondary

Measure	Time frame
1. Compare LUS scores at 4, 8, 12, 24 & 48 hours of life. 2. Compare duration of CPAP support between groups. 3. Compare need for intubation or surfactant therapy within 7 days. 4. Compare oxygen requirement (FiO2) at 4, 8, 12, 24 & 48 hours of life. 5. Compare incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestation or at discharge. 6. Compare NICU stay duration & in-hospital mortality. 7. Compare rates of hypothermia, apnea, bradycardia, & desaturation during first 72 hours. 8. Record adverse events: accidental CPAP dislodgement, infection/sepsis, & maternal issues. Timepoint: 4, 8, 12, 24 & 48 hours of life	—

Measure

Time frame

1. Compare LUS scores at 4, 8, 12, 24 & 48 hours of life. 2. Compare duration of CPAP support between groups. 3. Compare need for intubation or surfactant therapy within 7 days. 4. Compare oxygen requirement (FiO2) at 4, 8, 12, 24 & 48 hours of life. 5. Compare incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestation or at discharge. 6. Compare NICU stay duration & in-hospital mortality. 7. Compare rates of hypothermia, apnea, bradycardia, & desaturation during first 72 hours. 8. Record adverse events: accidental CPAP dislodgement, infection/sepsis, & maternal issues. Timepoint: 4, 8, 12, 24 & 48 hours of life

—

Countries

India

Contacts

Public ContactSomashekhar M Nimbalkar

Bhaikaka University

hitin.choudary@gmail.com9825087842

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026