Perinatal Asphyxia , Moderate to Severe HIEPhase 3MagsulfNCT00553072
Magnesium Sulphate in Perinatal Asphyxia
A Phase 3 study testing Magnesium sulphate and Normal saline in people with Perinatal Asphyxia , Moderate to Severe HIE, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
Trial summary
Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Perinatal Asphyxia , Moderate to Severe HIE
- What is being tested?
- Magnesium sulphate and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2004to Aug 2006
- Phase
- Phase 3
- 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 1 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies eligible for the study were:
- Term or post term
- Less than 6 hours of age and had
- severe perinatal asphyxia as manifested by any three of the following criteria.
- History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid)
- Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery
- A 5-minute Apgar score of < 6
- Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy
Who cannot join
- Patients with severe IUGR
- Any condition unrelated to asphyxia
- Maternal prenatal magnesium administration
- Metabolic disorder
- Chromosomal anomalies; and
- Congenital malformations were excluded from the study
Trial locations and contacts
1 site in 1 country.
India1 site
Sheri-Kashmir Institute of Medical Scienceds
Srinagar, Jammu and Kashmir
About this study
Official title: Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.
Read the detailed description
Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.
- Being tested
- Magnesium sulphate, Normal saline
- Keywords
- Asphyxia, perinatal, magnesium sulphate
- Medical subject headings
- Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
250 mg/kg/dose in 1 ml normal saline
Normal salineDrug
1 ml/kg/dose
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate, neurological outcome | Active comparator | Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth Receives: Drug: Magnesium sulphate |
| Placebo | Placebo comparator | Placebo every 24 hours for 3 doses starting from 6 hours after birth Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
good short term out come
Death and or abnormal neurological outcome at discharge
Measured: at discharge
Secondary outcomes (1)
abnormal neurological examination and abnormal CT Head
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startSep 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal Asphyxia , Moderate to Severe HIEStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheri Kashmir Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences
- Investigators
- Dr.Mushtaq A Bhat, M.D., Principal investigator, SKIMSDr.Javeed I Bhat, M.D., Study chair, SKIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553072
- Sponsor's protocol ID
- SKIMS-001
- Acronym
- Magsulf
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 2007
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhat MA, Charoo BA, Bhat JI, Ahmad SM, Ali SW, Mufti MU. Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial. Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6.
PubMed 19349375
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00553072
- Acronym / sponsor ID
- Magsulf / SKIMS-001
- Keywords
- Asphyxia, perinatal, magnesium sulphate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheri Kashmir Institute of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 5 Nov 2007 (estimated)
- 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.
Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.
Detailed description
Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate, neurological outcome | Active comparator | Drug: Magnesium sulphateMagnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth |
| Placebo | Placebo comparator | Drug: Normal salinePlacebo every 24 hours for 3 doses starting from 6 hours after birth |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Babies eligible for the study were:
Key exclusion criteria (6 listed)
- Patients with severe IUGR
- Any condition unrelated to asphyxia
- Maternal prenatal magnesium administration
- Metabolic disorder
- Chromosomal anomalies; and
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 |
|---|---|---|
| Magnesium sulphate250 mg/kg/dose in 1 ml normal saline | Drug | Magnesium sulphate, neurological outcome |
| Normal saline1 ml/kg/dose | Drug | Placebo |
Primary outcome
good short term out come
Time frame: at discharge
Death and or abnormal neurological outcome at discharge
1 secondary outcome
abnormal neurological examination and abnormal CT Head
Time frame: at discharge
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 14 Oct 2016.
- Derived from this study: PubMed 19349375Bhat MA, Charoo BA, Bhat JI, Ahmad SM, Ali SW, Mufti MU. Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial. Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6.
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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.
Dr.Mushtaq A Bhat, M.D. principal investigator
SKIMS
Dr.Javeed I Bhat, M.D. study chair
SKIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium sulphate and Normal saline in people with Perinatal Asphyxia , Moderate to Severe HIE, run by Sheri Kashmir Institute of Medical Sciences 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 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 14 Oct 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
good short term out come (time frame: at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553072, which also lists 1 linked publication.
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 14 Oct 2016.