Neonatal SepsisAbProMNCT01290003
Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor
A study testing Piperacillin-Tazobactam and Amikacin in people with Neonatal Sepsis, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. Read more about this study
- Who is it for?
- Ages 30 minutes to 2 hours
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Piperacillin-Tazobactam and Amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Jan 2011
- 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 > 37 weeks
- Meconium staining of amniotic fluid
- Cephalic presentation
- Singleton pregnancy
Who cannot join
- Major Congenital malformation
- Refusal of consent
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
About this study
Official title: Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial
The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation. It is believed that these babies are more prone to infections as meconium enhances bacterial growth and may predispose such babies to secondary bacterial infections. In addition, meconium passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics in babies born through meconium stained amniotic fluid will reduce the infectious episodes and complications thereof or not is not clear. Moreover, there is not much published literature to prove or refute the same. Most clinicians have a low threshold for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these babies, the investigators decided to investigate the role of prophylactic antibiotics in prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.
Read the detailed description
Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of the perinatal morbidity, occurring in 5-20% of all babies born through MSAF.
The routine use of antibiotics in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium passage in utero is hypothesized to represent a response to fetal bacterial infection in addition to intrauterine hypoxia. Additionally the rationale for use of antibiotics includes the radiographic similarity of MAS to bacterial pneumonia, in vitro enhancement of bacterial growth in presence of meconium as well as the possibility of meconium induced inhibition of phagocytic activity and respiratory burst response by alveolar macrophages rendering patients with MAS more susceptible to infection. These recommendations however are empirical and the incidence of bacterial infection in neonates born through MSAF as well as in MAS has not been systematically evaluated, to date. With the rising concern about the emergence of resistant strains in neonatal ICUs and the possible side effects of antibiotics (like amino glycosides) including nephrotoxicity and ototoxicity in neonates, a systematically conducted, randomized controlled trial is necessary to assess the utility of antibiotics in the routine management of infants with MSAF and MAS. Hence the purpose of this prospective randomized controlled trial is to compare the clinical course, complications, and infection related outcomes in cases of MSAF and MAS, treated with or without antibiotics therapy
- Conditions
- Neonatal Sepsis
- Being tested
- Piperacillin-Tazobactam and Amikacin
- Keywords
- Antibacterial agents, Neonate, Meconium stained amniotic fluid, Neonatal sepsis
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-Tazobactam and AmikacinDrug
Inj Piperacillin-Tazobactam 50 mg/Kg/dose 12 hourly IV X 3 days (6 doses) Inj Amikacin 15 mg/kg/dose 24 hourly IV X 3 days (3 doses)
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Group | Experimental | Neonates randomized to intervention Group(Antibiotic group)will receive the first line antibiotics (Piperacillin-Tazobactam and Amikacin) as per the unit policy for 72 hours. These neonates will also be monitored by performing sepsis screens and blood culture for development of sepsis. Receives: Drug: Piperacillin-Tazobactam and Amikacin |
| No Antibiotic Group | No intervention | Neonates randomized to 'No antibiotic group' will receive supportive treatment as per standard unit protocol. These neonates will be monitored by performing sepsis screens and blood culture for development of sepsis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sepsis
Incidence of sepsis in first 28 days defined as -
- SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or
- CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.
Sepsis Screen
- Total leukocyte count < 5000/mm3
- Absolute neutrophil count < 1800/cu.mm.(Low counts as per Monroe chart for term neonates)
- Immature/total neutrophil ratio > 0.2
- Micro-ESR > 15mm in 1st hour
- C Reactive Protein (CRP) > 1 mg/dl
Measured: First 28 days of life
Secondary outcomes (4)
Mortality;
Measured: First 28 days of life
Respiratory support;
- Requirement of respiratory support
- The mode of respiratory support viz. Supplemetal Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation
- Duration of each kind of respiratory support required
Measured: Till discharge from the hospital
Duration of Hospital stay
Measured: Till discharge
Complications
Incidence of PPHN by Echocardiography, Pneumothorax by transillumination confirmed by chest x-ray, azotemia by Kidney function test panel
Measured: Till discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
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 Neonatal SepsisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 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, Study chair, Lady Hardinge Medical College, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290003
- Sponsor's protocol ID
- LHMC/054/Ab-Pro-M
- Acronym
- AbProM
- Status last verified
- Sep 2015
- First submitted
- 3 Feb 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goel A, Nangia S, Saili A, Garg A, Sharma S, Randhawa VS. Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial. Eur J Pediatr. 2015 Feb;174(2):237-43. doi: 10.1007/s00431-014-2385-4. Epub 2014 Aug 3.
PubMed 25084971
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01290003
- Acronym / sponsor ID
- AbProM / LHMC/054/Ab-Pro-M
- Conditions
- Neonatal Sepsis
- Keywords
- Antibacterial agents, Neonate, Meconium stained amniotic fluid, Neonatal sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Feb 2011 (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.
The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation. It is believed that these babies are more prone to infections as meconium enhances bacterial growth and may predispose such babies to secondary bacterial infections. In addition, meconium passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics in babies born through meconium stained amniotic fluid will reduce the infectious episodes and complications thereof or not is not clear. Moreover, there is not much published literature to prove or refute the same. Most clinicians have a low threshold for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these babies, the investigators decided to investigate the role of prophylactic antibiotics in prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.
Detailed description
Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of the perinatal morbidity, occurring in 5-20% of all babies born through MSAF.
The routine use of antibiotics in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium passage in utero is hypothesized to represent a response to fetal bacterial infection in addition to intrauterine hypoxia. Additionally the rationale for use of antibiotics includes the radiographic similarity of MAS to bacterial pneumonia, in vitro enhancement of bacterial growth in presence of meconium as well as the possibility of meconium induced inhibition of phagocytic activity and respiratory burst response by alveolar macrophages rendering patients with MAS more susceptible to infection. These recommendations however are empirical and the incidence of bacterial infection in neonates born through MSAF as well as in MAS has not been systematically evaluated, to date. With the rising concern about the emergence of resistant strains in neonatal ICUs and the possible side effects of antibiotics (like amino glycosides) including nephrotoxicity and ototoxicity in neonates, a systematically conducted, randomized controlled trial is necessary to assess the utility of antibiotics in the routine management of infants with MSAF and MAS. Hence the purpose of this prospective randomized controlled trial is to compare the clinical course, complications, and infection related outcomes in cases of MSAF and MAS, treated with or without antibiotics therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Group | Experimental | Drug: Piperacillin-Tazobactam and AmikacinNeonates randomized to intervention Group(Antibiotic group)will receive the first line antibiotics (Piperacillin-Tazobactam and Amikacin) as per the unit policy for 72 hours. These neonates will also be monitored by performing sepsis screens and blood culture for development of sepsis. |
| No Antibiotic Group | No intervention | –Neonates randomized to 'No antibiotic group' will receive supportive treatment as per standard unit protocol. These neonates will be monitored by performing sepsis screens and blood culture for development of sepsis. |
Who may qualify
- Ages
- 30 minutes to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestation > 37 weeks
- Meconium staining of amniotic fluid
- Cephalic presentation
- Singleton pregnancy
Key exclusion criteria (2 listed)
- Major Congenital malformation
- Refusal of consent
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 |
|---|---|---|
| Piperacillin-Tazobactam and AmikacinInj Piperacillin-Tazobactam 50 mg/Kg/dose 12 hourly IV X 3 days (6 doses) Inj Amikacin 15 mg/kg/dose 24 hourly IV X 3 days (3 doses) | Drug | Antibiotic Group |
Primary outcome
Incidence of sepsis
Time frame: First 28 days of life
Incidence of sepsis in first 28 days 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 Monroe 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
4 secondary outcomes
Mortality;
Time frame: First 28 days of life
Respiratory support;
Time frame: Till discharge from the hospital
Duration of Hospital stay
Time frame: Till discharge
Complications
Time frame: Till 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 29 Sep 2015.
- Derived from this study: PubMed 25084971Goel A, Nangia S, Saili A, Garg A, Sharma S, Randhawa VS. Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial. Eur J Pediatr. 2015 Feb;174(2):237-43. doi: 10.1007/s00431-014-2385-4. Epub 2014 Aug 3.
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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 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 Piperacillin-Tazobactam and Amikacin in people with Neonatal Sepsis, 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 4 inclusion and 2 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 29 Sep 2015. 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?
Incidence of sepsis (time frame: First 28 days of life). 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 NCT01290003, 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 29 Sep 2015.