Meconium Aspiration SyndromeNCT06090981
Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
A study testing Bovine surfactant in people with Meconium Aspiration Syndrome and Surfactant Dysfunction, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care. Read more about this study
- Who is it for?
- Ages 30 minutes to 2 hours
- Conditions the study is for
- Meconium Aspiration Syndrome, Surfactant Dysfunction
- What is being tested?
- Bovine surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 12 Mar 2022to 12 Mar 2024
- Phase
- Interventional
- 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 30 minutes to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestation age ≥ 37 week
- Cephalic presentation
- Singleton pregnancy
- Age < 2 hours
- Baby delivered through meconium stained amniotic fluid
- Presence of respiratory distress (DOWNE's score ≥4)
Who cannot join
- Major congenital malformation
- Antenatal diagnosed CHD
- Hydrops fetalis
- Air leaks before enrolment
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: Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term (>=37 Weeks) Neonates With Actant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome: An Open Label Randomized Control Trial
The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.
Read the detailed description
Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care
Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life.
Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol
- Being tested
- Bovine surfactant
- Medical subject headings
- Meconium Aspiration Syndrome, Surfactant Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine surfactantDrug
Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Early bolus surfactant replacement therapy | Experimental | Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life Receives: Drug: Bovine surfactant |
| Standard care | No intervention | Neonates randomized to this group will be managed as per standard protocol in the neonatal unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Total respiratory support
Combined duration of invasive + non invasive ventilation
Measured: Birth to 28 days
Secondary outcomes (8)
Severity of respiratory distress
The severity of respiratory distress will be assessed using Downe's score. These parameters will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress
Measured: Birth to 28 days
Proportion of neonates requiring mechanical ventilation
The babies will be assessed for the need for mechanical ventilation as per standard protocol
Measured: Birth to 28 days
Proportion of neonates requiring Non Invasive Ventilation
The babies will be assessed for the need for non invasive ventilation as per standard protocol
Measured: Birth to 28 days
Duration of Mechanical Ventilation
Total duration of Mechanical Ventilation in days
Measured: Birth to 28 days
Duration of oxygen therapy
The duration of oxygen therapy, mode of delivery, Fio2 and flow rates will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress
Measured: Birth to 28 days
Complications
Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,
Measured: Birth to 28 days
Mortality
All cause mortality
Measured: Birth to 28 days
Duration of hospital stay
Total duration of hospital stay in days
Measured: Birth to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start12 Mar 2022
- Primary completion12 Feb 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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, MD, DM (Neo), Study chair, Lady Hardinge Medical College, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090981
- Sponsor's protocol ID
- LHMC/IEC/2021/03/69
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term (>=37 Weeks) Neonates With Actant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome: An Open Label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06090981
- Acronym / sponsor ID
- LHMC/IEC/2021/03/69
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 19 Oct 2023 (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.
The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.
Detailed description
Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care
Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life.
Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early bolus surfactant replacement therapy | Experimental | Drug: Bovine surfactantNeonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life |
| Standard care | No intervention | –Neonates randomized to this group will be managed as per standard protocol in the neonatal unit. |
Who may qualify
- Ages
- 30 minutes to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestation age ≥ 37 week
- Cephalic presentation
- Singleton pregnancy
- Age < 2 hours
- Baby delivered through meconium stained amniotic fluid
Key exclusion criteria (4 listed)
- Major congenital malformation
- Antenatal diagnosed CHD
- Hydrops fetalis
- Air leaks before enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine surfactantDose of surfactant: 4ml/kg Type of surfactant: 4ml/kg | Drug | Early bolus surfactant replacement therapy |
Primary outcome
Duration of Total respiratory support
Time frame: Birth to 28 days
Combined duration of invasive + non invasive ventilation
8 secondary outcomes
Severity of respiratory distress
Time frame: Birth to 28 days
Proportion of neonates requiring mechanical ventilation
Time frame: Birth to 28 days
Proportion of neonates requiring Non Invasive Ventilation
Time frame: Birth to 28 days
Duration of Mechanical Ventilation
Time frame: Birth to 28 days
Duration of oxygen therapy
Time frame: Birth to 28 days
Complications
Time frame: Birth to 28 days
Mortality
Time frame: Birth to 28 days
Duration of hospital stay
Time frame: Birth to 28 days
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 9 Jul 2024.
Related trials for Meconium Aspiration Syndrome
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
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, MD, DM (Neo) study chair
Lady Hardinge Medical College, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine surfactant in people with Meconium Aspiration Syndrome and Surfactant Dysfunction, 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 6 inclusion and 4 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 9 Jul 2024. 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?
Duration of Total respiratory support (time frame: Birth to 28 days). 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 9 Jul 2024.