A study to evaluate the benefits of an alternative method of breathing support to premature babies with breathing difficulty.

Not yet recruiting

Conditions: Preterm [premature] newborn [other],

Registration Number: CTRI/2023/06/053497

Lead Sponsor: Vishal Vishnu Tewari

Brief Summary: **What is already known:**

In preterm neonates RDS due to surfactant deficiency has been managed with intratracheal surfactant administration followed by invasive mechanical ventilation or extubation to non-invasive respiratory support in the form of non-synchronized nasal ventilation (NIV) or nasal continuous positive airway pressure (nCPAP) i.e. intubate, surfactant administration, extubation (INSURE) technique. Endotracheal intubation and positive pressure ventilation is the most important risk factor for unfavorable respiratory outcome in preterm neonates most notably BPD. With evolving management paradigms, NIV or nCPAP is preferred in premature infants. However nCPAP failure because of RDS especially in the most immature infants prompted search for a method for delivering surfactant in a less invasive manner (1). resulting in the development of the less invasive surfactant administration (LISA) technique with the aim to effectively provide an adequate dose of surfactant while the infant is breathing spontaneously with the support of nCPAP (2,3).

**What more is required to be known:** There is very limited and inconclusive evidence of LISA technique on short-term respiratory benefits in moderate to extreme preterm neonates. There are no indexed high-quality published studies on this from our country. This study would create evidence pertaining to decision for adapting LISA technique in neonatal intensive care units (NICUs) in our setting.

   **Why this study is required:** To evaluate LISA technique as a management modality for management of preterm RDS in moderate to extreme preterm neonates and to determine the short-term respiratory outcomes compared to currently followed techniques of surfactant administration and continued ventilation and INSURE. Additionally, the study will also propose a decision making algorithm for case selection of preterm neonates with RDS suitable for LISA technique.

**References:**

1.     Dargaville PA, Gerber A, Johansson S, et al. Australian and New Zealand Neonatal Network. Incidence and outcome of CPAP failure in preterm infants. Pediatrics 2016; 138: pii: e20153985.

2.     Kribs A, Pillekamp F, Hunseler C, et al. Early administration of surfactant in spontaneous breathing with nCPAP: feasibility and outcome in extremely premature infants (postmenstrual age 27 weeks). Paediatr Anaesth 2007; 17:364â€“369.

3.     Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed 2019; 104: F655â€“F659.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

All preterm neonates at and below 32 weeks period of gestation with moderate to severe RDS serially admitted to the NICU of Command hospital (WC), Chandimandir will be included in the study.

Exclusion Criteria

Neonates with major congenital anomalies, congenital heart diseases, gestation at and below 24 weeks or greater than 32 weeks, preterm neonates at and below 32 weeks with mild RDS not requiring intratracheal surfactant and neonates intubated at delivery for resuscitation.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.	To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.

Secondary Outcome Measures

Name	Time	Method
1.To determine the required number of doses of surfactant per patient	2.To determine the failure of LISA technique

Trial Locations

Locations (1): Neonatal Intensive Care Unit (NICU)
🇮🇳
Panchkula, HARYANA, India
Neonatal Intensive Care Unit (NICU)
🇮🇳Panchkula, HARYANA, India
Vishal Vishnu Tewari
Principal investigator
08826118889
docvvt_13@hotmail.com