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Meconium Aspiration SyndromeSur-Lu-LavNCT01310621

Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome

A study testing Bovine surfactant in people with Meconium Aspiration Syndrome, run by Lady Hardinge Medical College at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). Read more about this study

Who is it for?
Ages 30 minutes to 2 hours
Conditions the study is for
Meconium Aspiration Syndrome
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
Jan 2011to Apr 2012
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
  • Presence of meconium stained amniotic fluid or staining of meconium in skin,umbilical cord or nails.
  • Non vigorous babies
  • Presence of respiratory distress(Downes score ≥4)
  • Presence of meconium below vocal cords or chest x ray suggestive of meconium aspiration
  • Age < 2 hours

Who cannot join

  • Major congenital malformations
  • Congenital heart disease
  • Hydrops fetalis
  • Air leaks
  • Pulmonary hemorrhage

Trial locations and contacts

1 site in 1 country.

India1 site
  • Kalawati Saran children's Hospital, Lady Hardinge Medical College

    New Delhi, National Capital Territory of Delhi, 110001

Other trials in India

About this study

Official title: Surfactant Lung Lavage Versus Standard Care In The Treatment Of Meconium Aspiration Syndrome- A Randomized Controlled Study

The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium inhibits surfactant function directly and also decreases its synthesis by its toxic effects on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies with meconium aspiration. Surfactant replacement alone does not remove meconium from airways and multiple doses may be required .Therefore an effective therapy to improve outcome is crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by many pilot studies. So the investigators have decided to study the role surfactant lung lavage in the treatment of meconium aspiration syndrome.

Read the detailed description

Meconium is an odourless, thick, blackish green material first demonstrable in the foetal intestinal tract during the third month of gestation. Approximately 10-15% of deliveries are complicated by the passage of meconium around the time of delivery. The risk of meconium stained amniotic fluid (MSAF) is strongly correlated with gestational age. An adverse intrauterine environment with resultant foetal asphyxia is proposed as the most common explanation for MSAF.

Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). MAS is defined as respiratory distress with compatible chest x-ray finding in an infant born through MSAF whose symptoms cannot be otherwise explained. Despite current interventions such as intubation with tracheal suction, it is estimated that 5-20 % of infants born through MSAF develop MAS. It represents a leading cause of perinatal morbidity. Approximately 50% of the infants with MAS require mechanical ventilation; 15%-30% develop pulmonary air leaks and 5%-12% die.

The pathophysiology of meconium aspiration syndrome includes airway obstruction, surfactant inactivation, inflammation and pulmonary hypertension. Meconium itself inactivates the surfactant in the alveoli and its presence also causes secondary surfactant deficiency as meconium is toxic to type 2 alveolar cells which secrete surfactant. There is no specific treatment recommended for meconium aspiration syndrome .Treatment for MAS is generally supportive and includes supplemental oxygen as needed, assisted ventilation to maintain lung volume and improve gas exchange, and circulatory support with volume resuscitation and vasopressor infusions to maintain adequate perfusion. Successful treatment of meconium aspiration relies on effective meconium removal without inactivating or washing out surfactant, followed by appropriate ventilator care.

Surfactant replacement in neonates with severe meconium aspiration syndrome has been shown to improve oxygenation and reduce the severity of respiratory failure, air leaks and need for extracorporeal membrane oxygenation.

Surfactant replacement alone does not remove the meconium present in the airways and hence multiple doses may be required. Therefore an effective strategy to improve outcome in neonates with MAS needs to not only remove meconium but also retain the surfactant for adequate lung expansion and function.

Lung lavage using diluted surfactant has recently been shown to be an alternative to bolus therapy in treating MAS. This has advantage of removing surfactant inhibitors from alveolar space, in addition to augmenting surfactant concentration in alveolar space. Initial pilot case series using surfactant lung lavage have shown promise and there is a need to systematically study this in a RCT. The same has also been expressed in the literature on this subject. Hence the purpose of this prospective randomized controlled trial is to compare the efficacy of surfactant lung lavage over standard therapy in the treatment of meconium aspiration syndrome.

Being tested
Bovine surfactant
Keywords
Neonate, Meconium aspiration syndrome, surfactant lung lavage
Medical subject headings
Meconium Aspiration Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bovine surfactantDrug

    • Dose of diluted surfactant : 20ml/kg
    • Type :Bovine surfactant
    • Phospholipid concentration: 5 mg/ml
    • Number of lavages to be given: 2 (10ml/kg each)
Study groups in NCT01310621
Study groupRoleWhat they receive
No LavageNo interventionNeonate randomized to this group will be managed as per the standard protocol in the neonatal ward. The evaluation of respiratory distress will be done using Downe's score at hourly intervals till 24 hrs, followed by 2 hourly intervals till 72 hrs and finally 4 hourly intervals till resolution of clinical distress.
Surfactant LavageExperimentalThe diluted surfactant is instilled into endotracheal tube over a period of 15 to 20 seconds. Once the instillation is complete, 5 manual breaths will be provided and infant will be repositioned supine. The suction catheter will be inserted and advanced to a position approximately 5mm past the end of endotracheal tube. Suction will be activated for no more than 10 seconds and would be temporarily halted earlier if the oxygen saturation value falls by > 5% of the prelavage value. The same shall be resumed once prelavage oxygen saturation has been restored. The infant's bed will now be moved back to horizontal position. Once the neonate is STABLE, suctioning will be again repeated. The total retrieved volume is measured and recorded.This procedure will be done in both right and left lateral decubitus position
Receives: Drug: Bovine surfactant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of oxygen therapy in hours

    The duration of oxygen therapy, mode of delivery, FiO2 and flow rate will be documented hourly within first 2 hours before lavage and in post lavage- hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of oxygen therapy

    Measured: till discharge or death

  2. 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 lavage and in post lavage hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of respiratory distress

    Measured: till discharge or death

  3. need for mechanical ventilation

    The babies will be assessed for the need for mechanical ventilation as per standard unit protocols.

    Measured: till discharge or death

Secondary outcomes (5)
  1. Duration of mechanical ventilation

    Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

    Measured: till discharge or death

  2. Complications

    Incidence of PPHN by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.

    Measured: till discharge

  3. Incidence of sepsis

    Incidence of sepsis defined as -

    1. SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or
    2. CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.

    Sepsis Screen

    1. Total leukocyte count < 5000/mm3
    2. Absolute neutrophil count < 1800/cu.mm.(Low counts as per Manroe chart for term neonates)
    3. Immature/total neutrophil ratio > 0.2
    4. Micro-ESR > 15mm in 1st hour
    5. C Reactive Protein (CRP) > 1 mg/dl

    Measured: till discharge

  4. Mortality

    Measured: till discharge

  5. Duration of Hospital stay

    Measured: till discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2012
  4. Study completionApr 2012

Resources

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
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310621
Sponsor's protocol ID
LHMC/2011/Sur-Lu-Lav
Acronym
Sur-Lu-Lav
Status last verified
Jul 2014
First submitted
7 Mar 2011
Last updated
15 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Bovine surfactant in people with Meconium Aspiration Syndrome, 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 8 inclusion and 5 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 15 Jul 2014. 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 oxygen therapy in hours (time frame: till discharge or death). The study lists 3 primary outcomes in all. 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 15 Jul 2014.

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