Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy
Condition: Respiratory Distress Syndrome in Premature Infant; Surfactant; CPAP
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Observational

Summary: 
      To develop a comprehensive 'Clinical RD score' for decision making for administration of
      Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34
      6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of
      patients with similar gestational age.
    

Detailed description: 
      Respiratory distress syndrome, also known as hyaline membrane disease, occurs almost
      exclusively in premature infants. The incidence and severity of respiratory distress syndrome
      are inversely related to the gestational age of the newborn infant. The incidence of RDS is
      around 60 - 80% among infants < 28 weeks, 30-40% between 28-34 weeks, less than 5% at 34
      weeks and is rarely seen among those > 37 weeks.

      The availability of continuous positive airway pressure (CPAP) and natural surfactant have
      revolutionised the management of RDS. In 1967, Gregory et al. reported the value of
      application of continuous positive airway pressure in the management of RDS. Successful
      surfactant replacement therapy in RDS was reported by Fujiwara et al. Besides the use of
      Continuous positive airway pressure and surfactant replacement, the other advances include:
      Use of antenatal steroids to enhance pulmonary maturity, appropriate resuscitation and
      immediate use of CPAP for alveolar recruitment, Use of gentler modes of ventilation like
      patient triggered ventilation, Supportive therapies, such as the diagnosis and management of
      patent ductus arteriosus (PDA), fluid and electrolyte management, trophic feeding and
      nutrition.

      The use of CPAP applied to the alveoli has been shown to stabilise and improve respiratory
      distress in preterm babies. It preserves the action of endogenous surfactant and may also
      obviate the need for surfactant in a substantial number of cases. CPAP is cost effective and
      more patient friendly than mechanical ventilation. Availability of CPAP even at the district
      level Special Newborn Care Unit (SNCU) in various states across the country make it an ideal
      candidate for respiratory support in the high risk population.

      In addition to optimal respiratory support in the form of continuous positive airway pressure
      (CPAP) or mechanical ventilation and good supportive care, surfactant replacement therapy
      (SRT) forms the mainstay in the management of RDS. Since the report by Fujiwara in 1980 of
      the first successful use of SRT, numerous randomized controlled trials (RCTs) and their
      meta-analyses have established its efficacy in reducing mortality and air leak syndromes in
      RDS. Almost all the trials evaluating the role of SRT were conducted in high-income
      countries. Not surprisingly, SRT is the standard of care in neonates with RDS in these
      countries.

      The population in low and middle income countries (LMIC) like India may differ significantly
      from the western world. But whether the evidence from these high income countries can be
      extrapolated to LMICs, still remains questionable. High cost of surfactant therapy, issue
      regarding regular supply of the drug, lack of skilled personnel, poor antenatal steroid
      coverage of mothers with preterm labour, higher incidence of perinatal hypoxia/ischemia and
      infections all complicate the clinical course of RDS. The paucity of evidence for efficacy
      and/ or safety of SRT in these settings further add to the complexity.

      Continuous positive airway pressure (CPAP) remains as the first line of respiratory support
      in spontaneously breathing infants with RDS and surfactant is administered if required. The
      beneficial effects of surfactant are more pronounced when the therapy is started earlier. In
      most of the units across the country, the decision to administer surfactant to such babies
      managed on CPAP is clinician oriented and hence remains highly subjective. There are no
      objective criteria to decide for administration of surfactant to infants who are initially
      managed with CPAP. The current study was planned keeping in mind the beneficial effects of
      early CPAP and early surfactant, with the aim of developing an objective scoring system,
      which would guide the clinician in decision making for administration of surfactant to
      infants with RDS who are already being managed with CPAP.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of
        RDS.
      
Keywords: Preterm, RDS, Surfactant, CPAP