Respiratory Distress Syndrome in Premature InfantNCT03273764
Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy
An observational study of Respiratory Distress Syndrome in Premature Infant and Surfactant, run by Lady Hardinge Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 34 weeks
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant, Surfactant, CPAP
- How many people
- 209 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2015to 23 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of RDS.
Who may be able to join
- Neonates between 26 0/7-34 6/7 weeks of gestation who were delivered in the hospital with clinical diagnosis of respiratory distress syndrome were eligible for inclusion for the study.
Who cannot join
- Major congenital malformation
- Antenatally diagnosed congenital heart disease in fetus.
- Hydrops fetalis
- Massive Pulmonary hemorrhage prior to enrolment
- Shock requiring vasopressor support prior to enrolment
- Non availability of CPAP/ventilator in the unit.
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Development And Validation Of A Clinical RD Score For Decision Making For Administration Of Surfactant In Preterm Babies With RDS (Respiratory Distress Syndrome) - A Prospective Observational Study
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.
Read the 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.
- Keywords
- Preterm, RDS, Surfactant, CPAP
- Medical subject headings
- Premature Birth, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates with RDS | Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS
The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.
Measured: January 2015 to September 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Jan 2015
- Primary completion30 Sep 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome in Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, MBBS, MD, DM, Principal investigator, Kalawati Saran Chindren Hospital and Lady Hardinge Medical CollegeDebasish Nanda, MBBS, MD, Principal investigator, Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273764
- Sponsor's protocol ID
- LadyHardingeMedicalCollege
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Validation Of A Clinical RD Score For Decision Making For Administration Of Surfactant In Preterm Babies With RDS (Respiratory Distress Syndrome) - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03273764
- Acronym / sponsor ID
- LadyHardingeMedicalCollege
- Keywords
- Preterm, RDS, Surfactant, CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates with RDS | – | –Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies. |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of RDS.
Key inclusion criteria (1 listed)
- Neonates between 26 0/7-34 6/7 weeks of gestation who were delivered in the hospital with clinical diagnosis of respiratory distress syndrome were eligible for inclusion for the study.
Key exclusion criteria (6 listed)
- Major congenital malformation
- Antenatally diagnosed congenital heart disease in fetus.
- Hydrops fetalis
- Massive Pulmonary hemorrhage prior to enrolment
- Shock requiring vasopressor support prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS
Time frame: January 2015 to September 2016
The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushma Nangia, MBBS, MD, DM principal investigator
Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
Debasish Nanda, MBBS, MD principal investigator
Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome in Premature Infant and Surfactant, run by Lady Hardinge Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS (time frame: January 2015 to September 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.