Lung Ultrasound Score and its predictability for need of surfactant and grade of severity of respiratory distress syndrome in premature neonates -a Cohort study Study

Not yet recruiting

• Conditions: Respiratory distress syndrome of newborn,

• Registration Number: CTRI/2021/09/036770
• Lead Sponsor: Manish Swami

Brief Summary

Respiratory morbidities are fairly common in preterm newborns. Respiratory distress syndrome (RDS) in preterm neonates is a disease of surfactant deficiency (in premature lungs) that leads to diffuse atelectasis and alveolar collapse shortly after birth with high mortality and morbidity requiring admission and care in NICU. Respiratory distress syndrome (RDS) diagnosis is usually depending on patient’s clinical examination finding and Chest X-ray (CXR) findings. RDS is commonest indication requiring imaging in neonates. Repeated exposure for chest X ray required often for diagnosis, monitoring for therapy leads to ionizing radiation (IR) exposure to such small preterm neonates. Point of care ultrasonography (POCUS) of the lungs is a relatively easy, noninvasive procedure, and is useful to diagnose various lung conditions. Point of care ultrasonography(POCUS) helps in diagnosing, guiding and monitoring the treatment/surfactant administration. 

The POCUS score with six predefined area showed an inverse relation with lung aeration in neonates with respiratory distress syndrome. Each lung is classified into 3 areas (anterior superior, anterior inferior and lateral) with score 0-3, (total score 0-18). This scoring system is according to specific findings on lung ultrasonography.

All neonates who will meet the inclusion criteria and don’t have any of exclusion criteria, will be eligible and enrolled for the study.

POCUS score will be performed within 2 h of birth and in any case before surfactant administration. LUS Images/Scores will be recorded and saved in separate sheet, for each lung area by the operator (who was not the patient’s physician). These images / records will not be available to treating team. At the end of the study all the LUS images will be reanalyzed and the scores will be rechecked to a physician blinded to the patients’ clinical setting/condition.

During NICU course baby will be managed according to unit NICU protocol and after discharge/ demise data will be collected from record sheets (timing and dose of first surfactant administration, timing and dose of repeat surfactant administration if required, type and duration of respiratory support required, CPAP failure, and final outcome).

Appropriate statistical analysis will be done at the end of study (correlation between POCUS score and severity of RDS, surfactant need).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-22
• Study Start: 2021-09-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

All babies ≤32 weeks/ ≤1250gms with respiratory distress within first 2 hours of life irrespective of type respiratory support or requirement of resuscitation needed at birth.

Exclusion Criteria

• 1.Neonates with hemodynamic instabilities (severe sepsis/ refractory shock).
• 2.Neonates with antenatally detected intrathoracic malformations including congenital heart defects 3.Neonates with other associated respiratory morbidities (air-leaks, MAS, pulmonary haemorrhage) 4.Babies admitted to the NICU after administration of surfactant in the delivery room 5.Consent/ Assent not given by parents.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.POCUS Lung score will be assessed in 6 predefined areas of lung fields, Within 2 hours after birth and before administration of surfactant.	1.POCUS Lung score will be assessed in 6 predefined areas of lung fields, Within 2 hours after birth and before administration of surfactant. | 2.Requirement of surfactant-when baby on Nasal Continuous Positive Airway Pressure (NCPAP) 5 cm of water with FIO2 requirement ≥0.30 (≤26 weeks), or ≥0.40 (26 weeks) with target SpO2 of 91% – 95% (after 10 min of life)
2.Requirement of surfactant-when baby on Nasal Continuous Positive Airway Pressure (NCPAP) 5 cm of water with FIO2 requirement ≥0.30 (≤26 weeks), or ≥0.40 (26 weeks) with target SpO2 of 91% – 95% (after 10 min of life)	1.POCUS Lung score will be assessed in 6 predefined areas of lung fields, Within 2 hours after birth and before administration of surfactant. | 2.Requirement of surfactant-when baby on Nasal Continuous Positive Airway Pressure (NCPAP) 5 cm of water with FIO2 requirement ≥0.30 (≤26 weeks), or ≥0.40 (26 weeks) with target SpO2 of 91% – 95% (after 10 min of life)

Secondary Outcome Measures

Name	Time	Method
1.Oxygenation status-Oxygenation Index (OI),a/A ratio, S/F ratio,PaO2.	2.Nasal CPAP failure and need for invasive mechanical ventilation within the first 72 hours after birth.

Trial Locations

Locations (1)

AIIMS,Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

AIIMS,Bhubaneswar

🇮🇳Khordha, ORISSA, India

Manish Swami

Principal investigator

9991909318

dmanishswami@gmail.com