Neonatal SepsisNCT07888829
G-CSF In Neonatal Sepsis With Neutropenia
A study testing Granulocyte-colony stimulating factor (G-CSF) and Standard Sepsis Management in people with Neonatal Sepsis and Neutropenia, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia. It will compare survival, recovery of neutrophil counts, hospital stay, infections, and adverse effects between babies receiving G-CSF and standard treatment alone. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Sepsis, Neutropenia
- What is being tested?
- Granulocyte-colony stimulating factor (G-CSF) and Standard Sepsis Management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2027to 25 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates aged 0-28 days admitted to the Department of Neonatology/The Children's Hospital Lahore.
- Neonates diagnosed with sepsis according to the study's operational definition.
- Absolute neutrophil count (ANC) less than 1500/µL.
Who cannot join
- Neonates with congenital anomalies.
- Neonates with birth asphyxia.
- Neonates with primary immunodeficiency.
- Neonates already receiving treatment with colony-stimulating factor.
- Neonates already receiving any other adjuvant therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bushra Fatima contact
Pakistan1 site
Children's hospital University of Child Health Sciences Lahore
Lahore, Punjab Province, 54000
Children's hospital University of Child Health Sciences Lahore, 042-99230901-23, info@chich.edu.pk
About this study
Official title: Effectiveness Of Granulocyte-Colony Stimulating Factor(G-CSF) In Neonates With Neutropenia And Sepsis
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia. It will compare survival, recovery of neutrophil counts, hospital stay, infections, and adverse effects between babies receiving G-CSF and standard treatment alone.
Read the detailed description
This randomized controlled trial will evaluate the effectiveness of granulocyte-colony stimulating factor (G-CSF) as an adjuvant treatment in neonates with sepsis and neutropenia.
Neonatal sepsis is a clinical syndrome occurring during the first 28 days of life in which infection is associated with a systemic inflammatory response. In this study, neonatal sepsis will be identified on the basis of clinical features and laboratory findings, including signs of systemic inflammatory response syndrome (SIRS), positive blood, urine, or tracheal secretion cultures and/or elevated C-reactive protein (CRP). SIRS is defined by the presence of at least two specified criteria involving body temperature, heart rate, respiratory rate or PaCO2, and leukocyte count. Neutropenia is defined as an absolute neutrophil count (ANC) below 1500/µL.
G-CSF is a glycoprotein that promotes the growth, survival, and differentiation of neutrophils and enhances their antimicrobial activity. The study is based on the rationale that neutropenia in neonates with sepsis may be associated with poorer treatment outcomes because of limited neutrophil reserves and impaired recovery of neutrophil production. Increasing neutrophil counts through G-CSF administration may therefore improve the clinical course of affected neonates.
The study will be conducted in the Department of Neonatology at The Children's Hospital/The University of Child Health Sciences, Lahore, Pakistan. The planned study duration is at least six months after approval of the study synopsis.
A total of 52 neonates will be enrolled and divided into two groups of 26 participants each. The intervention group will receive standard sepsis management plus G-CSF at a dose of 10 µg/kg/day administered subcutaneously for three days. The control group will receive standard sepsis management alone. ANC will be monitored daily.
Eligible participants will be neonates aged 0-28 days admitted to the Department of Neonatology who meet the study definition of sepsis and have an ANC below 1500/µL. Neonates with congenital anomalies, birth asphyxia, primary immunodeficiency, or previous treatment with colony-stimulating factor or another adjuvant therapy will be excluded.
Data will be collected using a study proforma. Baseline clinical and laboratory information will be recorded, including gestational age, birth weight, clinical signs, blood culture results, complete blood count, ANC, CRP and other relevant laboratory findings. Following treatment, hematological parameters and clinical outcomes will be monitored.
The primary purpose of the study is to assess whether G-CSF improves clinical outcomes in neonates with sepsis and neutropenia. Outcomes assessed will include mortality, duration of neutropenia, duration of hospital stay, frequency of healthcare-associated infections, and adverse effects. Healthcare-associated infections assessed in the study include catheter-associated urinary tract infection, central-line-associated bloodstream infection, and ventilator-associated pneumonia.
The study will compare outcomes between neonates receiving standard sepsis management with G-CSF and those receiving standard sepsis management alone. Quantitative variables will be summarized using appropriate descriptive statistics, while qualitative variables will be presented as frequencies and percentages. Statistical comparisons will be performed using the planned statistical tests, with a p-value below 0.05 considered statistically significant.
The study is intended to determine whether G-CSF provides an additional clinical benefit when used alongside standard treatment in neonates with sepsis and neutropenia. Its findings may provide evidence to guide clinicians and inform future management of this high-risk neonatal population.
- Conditions
- Neonatal Sepsis, Neutropenia
- Being tested
- Granulocyte-colony stimulating factor (G-CSF), Standard Sepsis Management
- Keywords
- G-CSF, Neutrophil Count, Sepsis Treatment, Granulocyte-Colony Stimulating Factor, Neonatal Sepsis, Anti-Infective Agents
- Medical subject headings
- Neonatal Sepsis, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte-colony stimulating factor (G-CSF)Biological
Granulocyte-colony stimulating factor (G-CSF) will be administered to neonates with sepsis and neutropenia. G-CSF will be given at a dose of 10 µg/kg/day. The drug will be administered subcutaneously for 3 consecutive days. G-CSF will be given in addition to standard sepsis management. The intervention group consists of 26 neonates.
Standard Sepsis ManagementBiological
Neonates in the control group will receive standard sepsis management for the treatment of neonatal sepsis and neutropenia. No G-CSF will be administered to this group. The control group consists of 26 neonates. Outcomes will be monitored and recorded during the study. These include mortality, duration of neutropenia, duration of hospital stay, healthcare-associated infections, and adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF Plus Standard Sepsis Management | Active comparator | This group consists of 26 neonates with sepsis and neutropenia who receive G-CSF in addition to standard sepsis management. Receives: Biological: Granulocyte-colony stimulating factor (G-CSF) |
| Standard Sepsis Management Alone | Active comparator | This group consists of 26 neonates with sepsis and neutropenia who receive standard sepsis management without G-CSF. Receives: Biological: Standard Sepsis Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality among neonates with sepsis and neutropenia will be compared between the intervention group receiving G-CSF plus standard sepsis management and the control group receiving standard sepsis management alone.
Measured: From enrollment until discharge or death, within the first 28 days of life
Secondary outcomes (7)
Change in Absolute Neutrophil Count (ANC)
The absolute neutrophil count (ANC) will be measured before and after G-CSF administration to assess improvement in neutrophil count among neonates with sepsis and neutropenia.
Measured: Baseline through Day 3 (daily assessments during the 3-day treatment period)
Duration of Neutropenia
Duration of neutropenia will be assessed in neonates with sepsis and neutropenia and compared between the intervention and control groups. Neutropenia is defined as an absolute neutrophil count below 1500/µL.
Measured: From enrollment through hospital discharge, up to 28 days of life
Duration of Hospital Stay
The duration of hospitalization will be recorded for neonates in the intervention and control groups and compared to determine whether addition of G-CSF is associated with a shorter hospital stay.
Measured: From enrollment through hospital discharge, up to 28 days of life
Frequency of Healthcare-Associated Infections
The frequency of healthcare-associated infections will be recorded and compared between the intervention and control groups. Healthcare-associated infection is defined as a new episode of infection occurring ≥72 hours after G-CSF administration in a neonate initially admitted with sepsis and neutropenia.
Measured: From enrollment through hospital discharge, up to 28 days of life
Catheter-Associated Urinary Tract Infection (CAUTI)
The occurrence of catheter-associated urinary tract infection will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Measured: From enrollment through hospital discharge, up to 28 days of life
Central Line-Associated Bloodstream Infection (CLABSI)
The occurrence of central line-associated bloodstream infection will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Measured: From enrollment through hospital discharge, up to 28 days of life
Ventilator-Associated Pneumonia (VAP)
The occurrence of ventilator-associated pneumonia will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Measured: From enrollment through hospital discharge, up to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Feb 2027 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Yar, University of Health Sciences Lahore
- Investigators
- Bushra Fatima, Study chair, Children's hospital/ University of Child Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888829
- Sponsor's protocol ID
- 23-05-2026
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metcalf D. Hematopoietic cytokines. Blood. 2008 Jan 15;111(2):485-91. doi: 10.1182/blood-2007-03-079681.
PubMed 18182579Kaushansky K. Lineage-specific hematopoietic growth factors. N Engl J Med. 2006 May 11;354(19):2034-45. doi: 10.1056/NEJMra052706. No abstract available.
PubMed 16687716Khan TH, Shahidullah M, Mannan MA, Nahar N. Effect of recombinant human granulocyte colony stimulating factor (rhG-CSF) for the treatment of neonates in presumed sepsis with neutropenia. Mymensingh Med J. 2012 Jul;21(3):469-74.
PubMed 22828545Hoesel LM, Gao H, Ward PA. New insights into cellular mechanisms during sepsis. Immunol Res. 2006;34(2):133-41. doi: 10.1385/IR:34:2:133.
PubMed 16760573Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9.
PubMed 21146207Odabasi IO, Bulbul A. Neonatal Sepsis. Sisli Etfal Hastan Tip Bul. 2020 Jun 12;54(2):142-158. doi: 10.14744/SEMB.2020.00236. eCollection 2020.
PubMed 32617051Hamer DH, Coffin SE. Burden of Neonatal Sepsis in Low-resource Settings: High Risk, High Reward. Clin Infect Dis. 2021 Jul 15;73(2):281-282. doi: 10.1093/cid/ciaa550. No abstract available.
PubMed 32421766Fitchett EJA, Seale AC, Vergnano S, Sharland M, Heath PT, Saha SK, Agarwal R, Ayede AI, Bhutta ZA, Black R, Bojang K, Campbell H, Cousens S, Darmstadt GL, Madhi SA, Meulen AS, Modi N, Patterson J, Qazi S, Schrag SJ, Stoll BJ, Wall SN, Wammanda RD, Lawn JE; SPRING (Strengthening Publications Reporting Infection in Newborns Globally) Group. Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research. Lancet Infect Dis. 2016 Oct;16(10):e202-e213. doi: 10.1016/S1473-3099(16)30082-2. Epub 2016 Sep 12.
PubMed 27633910
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Granulocyte-Colony Stimulating Factor(G-CSF) In Neonates With Neutropenia And Sepsis
- ClinicalTrials.gov ID
- NCT07888829
- Acronym / sponsor ID
- 23-05-2026
- Conditions
- Neonatal Sepsis, Neutropenia
- Keywords
- G-CSF, Neutrophil Count, Sepsis Treatment, Granulocyte-Colony Stimulating Factor, Neonatal Sepsis, Anti-Infective Agents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 15 Feb 2027 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia. It will compare survival, recovery of neutrophil counts, hospital stay, infections, and adverse effects between babies receiving G-CSF and standard treatment alone.
Detailed description
This randomized controlled trial will evaluate the effectiveness of granulocyte-colony stimulating factor (G-CSF) as an adjuvant treatment in neonates with sepsis and neutropenia.
Neonatal sepsis is a clinical syndrome occurring during the first 28 days of life in which infection is associated with a systemic inflammatory response. In this study, neonatal sepsis will be identified on the basis of clinical features and laboratory findings, including signs of systemic inflammatory response syndrome (SIRS), positive blood, urine, or tracheal secretion cultures and/or elevated C-reactive protein (CRP). SIRS is defined by the presence of at least two specified criteria involving body temperature, heart rate, respiratory rate or PaCO2, and leukocyte count. Neutropenia is defined as an absolute neutrophil count (ANC) below 1500/µL.
G-CSF is a glycoprotein that promotes the growth, survival, and differentiation of neutrophils and enhances their antimicrobial activity. The study is based on the rationale that neutropenia in neonates with sepsis may be associated with poorer treatment outcomes because of limited neutrophil reserves and impaired recovery of neutrophil production. Increasing neutrophil counts through G-CSF administration may therefore improve the clinical course of affected neonates.
The study will be conducted in the Department of Neonatology at The Children's Hospital/The University of Child Health Sciences, Lahore, Pakistan. The planned study duration is at least six months after approval of the study synopsis.
A total of 52 neonates will be enrolled and divided into two groups of 26 participants each. The intervention group will receive standard sepsis management plus G-CSF at a dose of 10 µg/kg/day administered subcutaneously for three days. The control group will receive standard sepsis management alone. ANC will be monitored daily.
Eligible participants will be neonates aged 0-28 days admitted to the Department of Neonatology who meet the study definition of sepsis and have an ANC below 1500/µL. Neonates with congenital anomalies, birth asphyxia, primary immunodeficiency, or previous treatment with colony-stimulating factor or another adjuvant therapy will be excluded.
Data will be collected using a study proforma. Baseline clinical and laboratory information will be recorded, including gestational age, birth weight, clinical signs, blood culture results, complete blood count, ANC, CRP and other relevant laboratory findings. Following treatment, hematological parameters and clinical outcomes will be monitored.
The primary purpose of the study is to assess whether G-CSF improves clinical outcomes in neonates with sepsis and neutropenia. Outcomes assessed will include mortality, duration of neutropenia, duration of hospital stay, frequency of healthcare-associated infections, and adverse effects. Healthcare-associated infections assessed in the study include catheter-associated urinary tract infection, central-line-associated bloodstream infection, and ventilator-associated pneumonia.
The study will compare outcomes between neonates receiving standard sepsis management with G-CSF and those receiving standard sepsis management alone. Quantitative variables will be summarized using appropriate descriptive statistics, while qualitative variables will be presented as frequencies and percentages. Statistical comparisons will be performed using the planned statistical tests, with a p-value below 0.05 considered statistically significant.
The study is intended to determine whether G-CSF provides an additional clinical benefit when used alongside standard treatment in neonates with sepsis and neutropenia. Its findings may provide evidence to guide clinicians and inform future management of this high-risk neonatal population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF Plus Standard Sepsis Management | Active comparator | Biological: Granulocyte-colony stimulating factor (G-CSF)This group consists of 26 neonates with sepsis and neutropenia who receive G-CSF in addition to standard sepsis management. |
| Standard Sepsis Management Alone | Active comparator | Biological: Standard Sepsis ManagementThis group consists of 26 neonates with sepsis and neutropenia who receive standard sepsis management without G-CSF. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates aged 0-28 days admitted to the Department of Neonatology/The Children's Hospital Lahore.
- Neonates diagnosed with sepsis according to the study's operational definition.
- Absolute neutrophil count (ANC) less than 1500/µL.
Key exclusion criteria (5 listed)
- Neonates with congenital anomalies.
- Neonates with birth asphyxia.
- Neonates with primary immunodeficiency.
- Neonates already receiving treatment with colony-stimulating factor.
- Neonates already receiving any other adjuvant therapy.
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 |
|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF)Granulocyte-colony stimulating factor (G-CSF) will be administered to neonates with sepsis and neutropenia. G-CSF will be given at a dose of 10 µg/kg/day. The drug will be administered subcutaneously for 3 consecutive days. G-CSF will be given in addition to standard sepsis management. The intervention group consists of 26 neonates. | Biological | G-CSF Plus Standard Sepsis Management |
| Standard Sepsis ManagementNeonates in the control group will receive standard sepsis management for the treatment of neonatal sepsis and neutropenia. No G-CSF will be administered to this group. The control group consists of 26 neonates. Outcomes will be monitored and recorded during the study. These include mortality, duration of neutropenia, duration of hospital stay, healthcare-associated infections, and adverse effects. | Biological | Standard Sepsis Management Alone |
Primary outcome
Mortality
Time frame: From enrollment until discharge or death, within the first 28 days of life
Mortality among neonates with sepsis and neutropenia will be compared between the intervention group receiving G-CSF plus standard sepsis management and the control group receiving standard sepsis management alone.
7 secondary outcomes
Change in Absolute Neutrophil Count (ANC)
Time frame: Baseline through Day 3 (daily assessments during the 3-day treatment period)
Duration of Neutropenia
Time frame: From enrollment through hospital discharge, up to 28 days of life
Duration of Hospital Stay
Time frame: From enrollment through hospital discharge, up to 28 days of life
Frequency of Healthcare-Associated Infections
Time frame: From enrollment through hospital discharge, up to 28 days of life
Catheter-Associated Urinary Tract Infection (CAUTI)
Time frame: From enrollment through hospital discharge, up to 28 days of life
Central Line-Associated Bloodstream Infection (CLABSI)
Time frame: From enrollment through hospital discharge, up to 28 days of life
Ventilator-Associated Pneumonia (VAP)
Time frame: From enrollment through hospital discharge, up to 28 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 18182579Metcalf D. Hematopoietic cytokines. Blood. 2008 Jan 15;111(2):485-91. doi: 10.1182/blood-2007-03-079681.
- Background: PubMed 16687716Kaushansky K. Lineage-specific hematopoietic growth factors. N Engl J Med. 2006 May 11;354(19):2034-45. doi: 10.1056/NEJMra052706. No abstract available.
- Background: PubMed 22828545Khan TH, Shahidullah M, Mannan MA, Nahar N. Effect of recombinant human granulocyte colony stimulating factor (rhG-CSF) for the treatment of neonates in presumed sepsis with neutropenia. Mymensingh Med J. 2012 Jul;21(3):469-74.
- Background: PubMed 16760573Hoesel LM, Gao H, Ward PA. New insights into cellular mechanisms during sepsis. Immunol Res. 2006;34(2):133-41. doi: 10.1385/IR:34:2:133.
- Background: PubMed 21146207Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9.
- Background: PubMed 32617051Odabasi IO, Bulbul A. Neonatal Sepsis. Sisli Etfal Hastan Tip Bul. 2020 Jun 12;54(2):142-158. doi: 10.14744/SEMB.2020.00236. eCollection 2020.
- Background: PubMed 32421766Hamer DH, Coffin SE. Burden of Neonatal Sepsis in Low-resource Settings: High Risk, High Reward. Clin Infect Dis. 2021 Jul 15;73(2):281-282. doi: 10.1093/cid/ciaa550. No abstract available.
- Background: PubMed 27633910Fitchett EJA, Seale AC, Vergnano S, Sharland M, Heath PT, Saha SK, Agarwal R, Ayede AI, Bhutta ZA, Black R, Bojang K, Campbell H, Cousens S, Darmstadt GL, Madhi SA, Meulen AS, Modi N, Patterson J, Qazi S, Schrag SJ, Stoll BJ, Wall SN, Wammanda RD, Lawn JE; SPRING (Strengthening Publications Reporting Infection in Newborns Globally) Group. Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research. Lancet Infect Dis. 2016 Oct;16(10):e202-e213. doi: 10.1016/S1473-3099(16)30082-2. Epub 2016 Sep 12.
- Newborns: improving survival and well-beingLink provided by the sponsor.
- Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection researchLink provided by the sponsor.
- NEONATAL SEPSIS IN A TERTIARY CARE HOSPITAL: BACTERIOLOGICAL PROFILE AND ITS ANTIBICROBIAL SENSITIVITYLink provided by the sponsor.
- Neonatal SepsisLink provided by the sponsor.
- Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysisLink provided by the sponsor.
- Newborn mortalityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bushra Fatima contact
Bushra Fatima study chair
Children's hospital/ University of Child Health Sciences Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Granulocyte-colony stimulating factor (G-CSF) and Standard Sepsis Management in people with Neonatal Sepsis and Neutropenia, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 3 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nayyab Tahir, Clinical Fellow Neonatology (+92 336 7744073, m.nayyabtahir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From enrollment until discharge or death, within the 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 NCT07888829, which also lists 8 linked publications.
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 22 Oct 2026.