Child MortalityNCT02233127
Birth Cohort in Rahimyar Khan, Pakistan
An observational study of Child Mortality and Child Morbidity, run by The Hospital for Sick Children at 1 site in Pakistan.
Trial summary
In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of the causes of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Child Mortality, Child Morbidity, Child Development
- How many people
- 2,271 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2014to 22 Jul 2016
- Phase
- Observational
- 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 day to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: This study will be conducted in Rahimyar Khan (RYK) in Punjab Province, Pakistan and follows a longitudinal birth cohort design that will be conducted alongside a community-based, cluster randomized intervention trial in RYK (NCT02130856). In the concurrent intervention trial, approximately 6000 pregnant women and their unborn babies will be enrolled to participate in either the control or intervention arm of the trial; approximately half of the women will be enrolled to the control arm and half will be enrolled to the intervention arm. At the time of enrolment, women in the control arm of the trial will also be asked to participate in the birth cohort study.
Who may be able to join
- All pregnant women and their home- or facility-born live newborns that consented to participate in the control arm of the intervention trial "An integrated toolkit to save newborn lives in Pakistan" (NCT02130856) will be eligible for this study
Who cannot join
- Did not consent to participate in the control arm of "An integrated toolkit to save newborn lives in Pakistan"(NCT02130856). Since the birth cohort study has been designed to utilize a portion of the data collected in the neonatal kit trial, individuals who do not enroll in the kit study will not be eligible to participate in birth cohort study as they will not have a complete set of data.
- Failure to provide consent to enroll in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Birth Cohort Study in Rahimyar Khan, Pakistan
In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of the causes of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Prospective birth cohort studies present an opportunity to examine the relationships between early-life exposures and multiple health and non-health related outcomes including death, illness, and socioeconomic factors. In this study, we will provide insight into the underlying causes of child mortality by collecting high-quality data on early-life exposures and health and non-health related outcomes in the first year of life.
Read the detailed description
In 2010, 7.6 million children under the age of five died worldwide (Liu et al., 2012). Notably, the burden of under-five mortality varies dramatically by country. The majority of total child deaths in 2010 were seen in Africa (3.6 million) and southeast Asia (2.1 million deaths), compared to 0.16 million and 0.28 million under-five deaths in Europe and the Americas, respectively (Liu et al., 2012). Strikingly, nearly half of the world's under-five child deaths in 2010 could be attributed to only five countries: India, Nigeria, Democratic Republic of the Congo, Pakistan, and China (Liu et al., 2012). In Pakistan alone, over 420,000 under-five child deaths occurred in 2010 (Liu et al., 2012).
A thorough understanding of the etiology of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Importantly, in 2010, the causes of only 2.7% (0.205 million) of all deaths in children under the age of five were medically certified (Liu et al., 2012), highlighting the need to gather high-quality data on the causes of mortality.
Prospective longitudinal birth cohort studies present an opportunity to examine temporal relationships between early-life exposures (i.e. prenatal, pregnancy, and early postnatal exposures) and multiple health and non-health related outcomes including mortality, morbidity, and socioeconomic position. It is well documented that exposures that occur early in life, including genetic, environmental, socioeconomic, and lifestyle factors, may have long-lasting effects on growth, development, and health outcomes throughout an individual's entire life course (Lynch \& Smith, 2005). Thus, data on exposures during pregnancy and early childhood are valuable and may provide clues to the etiology of long-term outcomes.
Additional value can be gained through cross-cohort collaborations and comparisons (Larsen et al., 2013)(Paternoster et al., 2012)(Brion et al., 2011). By pooling data from multiple cohort studies, causal inferences can be made with greater confidence. In addition, through cross-country comparisons, heterogeneity in exposures is often increased making it more likely that an association between exposure and outcome will be observed. Similarly, cross-cohort comparisons enable researchers to investigate patterns associated with health, social, and economic outcomes in distinct regions of the world. These types of analyses may provide valuable insight into the underlying causes of global health inequalities.
The objective of this study is to implement a longitudinal prospective birth cohort study in Pakistan to obtain extensive and high-quality information on early-life exposures and health and non-health related outcomes in the first year of life. Concurrent to the design and implementation of this cohort study in Pakistan, similar studies are being implemented in Kenya (Coastal Region Cohort, Lead PI: Dr. Shaun Morris), Brazil (Pelotas Cohort, Lead PIs: Dr. Pedro R.C. Hallal, Dr. Diego G. Bassani and Dr. Mariangela Silveira), and South Africa (Birth to Twenty Cohort, Lead PI: Dr. Shane Norris). The investigators of each project have communicated their intent to align study materials in an effort to increase the ease of future comparisons between findings. This study will therefore be one crucial pillar in a multi-country cross-cohort comparison and presents a unique opportunity to investigate and compare the patterns that shape health and non-health related outcomes in individuals from four distinct regions in the world.
- Conditions
- Child Mortality, Child Morbidity, Child Development, Child Behaviour
- Keywords
- Birth cohort, Pakistan, Child mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Birth Cohort | The cohort will comprise approximately 3000 pregnant women and their unborn babies, enrolled to participate in the control arm of a cluster-randomized controlled intervention trial (NCT02130856). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within the first year of life
Death from any cause within the first year of life. Assessed by questionnaire.
Measured: Day 3 of life, month 6 of life, month 12 of life
Secondary outcomes (2)
Morbidity within the first year of a child's life
The most common types of illness within the first year of a child's life will be assessed by questionnaire.
Measured: Day 3 of life, month 6 of life, month 12 of life
Development/behaviour of children aged 6 and 12 months in RYK, Pakistan
Assessed by questionnaire (12 month by adapted BSID-III)
.
Measured: Month 6 of life, month 12 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion22 Jul 2016
- Study completion22 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Child MortalityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- March of Dimes, Aga Khan University
- Responsible party
- Principal investigator, Shaun Morris, The Hospital for Sick Children
- Investigators
- Shaun K Morris, MD, MPH, Principal investigator, The Hospital for Sick ChildrenZulfiqar A. Bhutta, PhD, MBBS, Principal investigator, Aga Khan University and The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233127
- Sponsor's protocol ID
- 1000045918
- Status last verified
- Apr 2017
- First submitted
- 5 Aug 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125Larsen PS, Kamper-Jorgensen M, Adamson A, Barros H, Bonde JP, Brescianini S, Brophy S, Casas M, Charles MA, Devereux G, Eggesbo M, Fantini MP, Frey U, Gehring U, Grazuleviciene R, Henriksen TB, Hertz-Picciotto I, Heude B, Hryhorczuk DO, Inskip H, Jaddoe VW, Lawlor DA, Ludvigsson J, Kelleher C, Kiess W, Koletzko B, Kuehni CE, Kull I, Kyhl HB, Magnus P, Momas I, Murray D, Pekkanen J, Polanska K, Porta D, Poulsen G, Richiardi L, Roeleveld N, Skovgaard AM, Sram RJ, Strandberg-Larsen K, Thijs C, Van Eijsden M, Wright J, Vrijheid M, Andersen AM. Pregnancy and birth cohort resources in europe: a large opportunity for aetiological child health research. Paediatr Perinat Epidemiol. 2013 Jul;27(4):393-414. doi: 10.1111/ppe.12060.
PubMed 23772942Lynch J, Smith GD. A life course approach to chronic disease epidemiology. Annu Rev Public Health. 2005;26:1-35. doi: 10.1146/annurev.publhealth.26.021304.144505.
PubMed 15760279Brion MJ, Zeegers M, Jaddoe V, Verhulst F, Tiemeier H, Lawlor DA, Smith GD. Intrauterine effects of maternal prepregnancy overweight on child cognition and behavior in 2 cohorts. Pediatrics. 2011 Jan;127(1):e202-11. doi: 10.1542/peds.2010-0651. Epub 2010 Dec 27.
PubMed 21187310Paternoster L, Standl M, Chen CM, Ramasamy A, Bonnelykke K, Duijts L, Ferreira MA, Alves AC, Thyssen JP, Albrecht E, Baurecht H, Feenstra B, Sleiman PM, Hysi P, Warrington NM, Curjuric I, Myhre R, Curtin JA, Groen-Blokhuis MM, Kerkhof M, Saaf A, Franke A, Ellinghaus D, Folster-Holst R, Dermitzakis E, Montgomery SB, Prokisch H, Heim K, Hartikainen AL, Pouta A, Pekkanen J, Blakemore AI, Buxton JL, Kaakinen M, Duffy DL, Madden PA, Heath AC, Montgomery GW, Thompson PJ, Matheson MC, Le Souef P; Australian Asthma Genetics Consortium (AAGC); St Pourcain B, Smith GD, Henderson J, Kemp JP, Timpson NJ, Deloukas P, Ring SM, Wichmann HE, Muller-Nurasyid M, Novak N, Klopp N, Rodriguez E, McArdle W, Linneberg A, Menne T, Nohr EA, Hofman A, Uitterlinden AG, van Duijn CM, Rivadeneira F, de Jongste JC, van der Valk RJ, Wjst M, Jogi R, Geller F, Boyd HA, Murray JC, Kim C, Mentch F, March M, Mangino M, Spector TD, Bataille V, Pennell CE, Holt PG, Sly P, Tiesler CM, Thiering E, Illig T, Imboden M, Nystad W, Simpson A, Hottenga JJ, Postma D, Koppelman GH, Smit HA, Soderhall C, Chawes B, Kreiner-Moller E, Bisgaard H, Melen E, Boomsma DI, Custovic A, Jacobsson B, Probst-Hensch NM, Palmer LJ, Glass D, Hakonarson H, Melbye M, Jarvis DL, Jaddoe VW, Gieger C; Genetics of Overweight Young Adults (GOYA) Consortium; Strachan DP, Martin NG, Jarvelin MR, Heinrich J, Evans DM, Weidinger S; EArly Genetics & Lifecourse Epidemiology (EAGLE) Consortium. Meta-analysis of genome-wide association studies identifies three new risk loci for atopic dermatitis. Nat Genet. 2011 Dec 25;44(2):187-92. doi: 10.1038/ng.1017.
PubMed 22197932
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Birth Cohort Study in Rahimyar Khan, Pakistan
- ClinicalTrials.gov ID
- NCT02233127
- Acronym / sponsor ID
- 1000045918
- Conditions
- Child Mortality, Child Morbidity, Child Development, Child Behaviour
- Keywords
- Birth cohort, Pakistan, Child mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,271 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- March of Dimes, Aga Khan University
- Study start
- Oct 2014
- Primary completion
- 22 Jul 2016 (actual)
- Study completion
- 22 Jul 2016 (actual)
- First posted
- 8 Sep 2014 (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.
In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of the causes of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Prospective birth cohort studies present an opportunity to examine the relationships between early-life exposures and multiple health and non-health related outcomes including death, illness, and socioeconomic factors. In this study, we will provide insight into the underlying causes of child mortality by collecting high-quality data on early-life exposures and health and non-health related outcomes in the first year of life.
Detailed description
In 2010, 7.6 million children under the age of five died worldwide (Liu et al., 2012). Notably, the burden of under-five mortality varies dramatically by country. The majority of total child deaths in 2010 were seen in Africa (3.6 million) and southeast Asia (2.1 million deaths), compared to 0.16 million and 0.28 million under-five deaths in Europe and the Americas, respectively (Liu et al., 2012). Strikingly, nearly half of the world's under-five child deaths in 2010 could be attributed to only five countries: India, Nigeria, Democratic Republic of the Congo, Pakistan, and China (Liu et al., 2012). In Pakistan alone, over 420,000 under-five child deaths occurred in 2010 (Liu et al., 2012).
A thorough understanding of the etiology of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Importantly, in 2010, the causes of only 2.7% (0.205 million) of all deaths in children under the age of five were medically certified (Liu et al., 2012), highlighting the need to gather high-quality data on the causes of mortality.
Prospective longitudinal birth cohort studies present an opportunity to examine temporal relationships between early-life exposures (i.e. prenatal, pregnancy, and early postnatal exposures) and multiple health and non-health related outcomes including mortality, morbidity, and socioeconomic position. It is well documented that exposures that occur early in life, including genetic, environmental, socioeconomic, and lifestyle factors, may have long-lasting effects on growth, development, and health outcomes throughout an individual's entire life course (Lynch \& Smith, 2005). Thus, data on exposures during pregnancy and early childhood are valuable and may provide clues to the etiology of long-term outcomes.
Additional value can be gained through cross-cohort collaborations and comparisons (Larsen et al., 2013)(Paternoster et al., 2012)(Brion et al., 2011). By pooling data from multiple cohort studies, causal inferences can be made with greater confidence. In addition, through cross-country comparisons, heterogeneity in exposures is often increased making it more likely that an association between exposure and outcome will be observed. Similarly, cross-cohort comparisons enable researchers to investigate patterns associated with health, social, and economic outcomes in distinct regions of the world. These types of analyses may provide valuable insight into the underlying causes of global health inequalities.
The objective of this study is to implement a longitudinal prospective birth cohort study in Pakistan to obtain extensive and high-quality information on early-life exposures and health and non-health related outcomes in the first year of life. Concurrent to the design and implementation of this cohort study in Pakistan, similar studies are being implemented in Kenya (Coastal Region Cohort, Lead PI: Dr. Shaun Morris), Brazil (Pelotas Cohort, Lead PIs: Dr. Pedro R.C. Hallal, Dr. Diego G. Bassani and Dr. Mariangela Silveira), and South Africa (Birth to Twenty Cohort, Lead PI: Dr. Shane Norris). The investigators of each project have communicated their intent to align study materials in an effort to increase the ease of future comparisons between findings. This study will therefore be one crucial pillar in a multi-country cross-cohort comparison and presents a unique opportunity to investigate and compare the patterns that shape health and non-health related outcomes in individuals from four distinct regions in the world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Birth Cohort | – | –The cohort will comprise approximately 3000 pregnant women and their unborn babies, enrolled to participate in the control arm of a cluster-randomized controlled intervention trial (NCT02130856). |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will be conducted in Rahimyar Khan (RYK) in Punjab Province, Pakistan and follows a longitudinal birth cohort design that will be conducted alongside a community-based, cluster randomized intervention trial in RYK (NCT02130856). In the concurrent intervention trial, approximately 6000 pregnant women and their unborn babies will be enrolled to participate in either the control or intervention arm of the trial; approximately half of the women will be enrolled to the control arm and half will be enrolled to the intervention arm. At the time of enrolment, women in the control arm of the trial will also be asked to participate in the birth cohort study.
Key inclusion criteria (1 listed)
- All pregnant women and their home- or facility-born live newborns that consented to participate in the control arm of the intervention trial "An integrated toolkit to save newborn lives in Pakistan" (NCT02130856) will be eligible for this study
Key exclusion criteria (2 listed)
- Did not consent to participate in the control arm of "An integrated toolkit to save newborn lives in Pakistan"(NCT02130856). Since the birth cohort study has been designed to utilize a portion of the data collected in the neonatal kit trial, individuals who do not enroll in the kit study will not be eligible to participate in birth cohort study as they will not have a complete set of data.
- Failure to provide consent to enroll in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality within the first year of life
Time frame: Day 3 of life, month 6 of life, month 12 of life
Death from any cause within the first year of life. Assessed by questionnaire.
2 secondary outcomes
Morbidity within the first year of a child's life
Time frame: Day 3 of life, month 6 of life, month 12 of life
Development/behaviour of children aged 6 and 12 months in RYK, Pakistan
Time frame: Month 6 of life, month 12 of life
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 25 Apr 2017.
- Background: PubMed 22579125Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Background: PubMed 23772942Larsen PS, Kamper-Jorgensen M, Adamson A, Barros H, Bonde JP, Brescianini S, Brophy S, Casas M, Charles MA, Devereux G, Eggesbo M, Fantini MP, Frey U, Gehring U, Grazuleviciene R, Henriksen TB, Hertz-Picciotto I, Heude B, Hryhorczuk DO, Inskip H, Jaddoe VW, Lawlor DA, Ludvigsson J, Kelleher C, Kiess W, Koletzko B, Kuehni CE, Kull I, Kyhl HB, Magnus P, Momas I, Murray D, Pekkanen J, Polanska K, Porta D, Poulsen G, Richiardi L, Roeleveld N, Skovgaard AM, Sram RJ, Strandberg-Larsen K, Thijs C, Van Eijsden M, Wright J, Vrijheid M, Andersen AM. Pregnancy and birth cohort resources in europe: a large opportunity for aetiological child health research. Paediatr Perinat Epidemiol. 2013 Jul;27(4):393-414. doi: 10.1111/ppe.12060.
- Background: PubMed 15760279Lynch J, Smith GD. A life course approach to chronic disease epidemiology. Annu Rev Public Health. 2005;26:1-35. doi: 10.1146/annurev.publhealth.26.021304.144505.
- Background: PubMed 21187310Brion MJ, Zeegers M, Jaddoe V, Verhulst F, Tiemeier H, Lawlor DA, Smith GD. Intrauterine effects of maternal prepregnancy overweight on child cognition and behavior in 2 cohorts. Pediatrics. 2011 Jan;127(1):e202-11. doi: 10.1542/peds.2010-0651. Epub 2010 Dec 27.
- Background: PubMed 22197932Paternoster L, Standl M, Chen CM, Ramasamy A, Bonnelykke K, Duijts L, Ferreira MA, Alves AC, Thyssen JP, Albrecht E, Baurecht H, Feenstra B, Sleiman PM, Hysi P, Warrington NM, Curjuric I, Myhre R, Curtin JA, Groen-Blokhuis MM, Kerkhof M, Saaf A, Franke A, Ellinghaus D, Folster-Holst R, Dermitzakis E, Montgomery SB, Prokisch H, Heim K, Hartikainen AL, Pouta A, Pekkanen J, Blakemore AI, Buxton JL, Kaakinen M, Duffy DL, Madden PA, Heath AC, Montgomery GW, Thompson PJ, Matheson MC, Le Souef P; Australian Asthma Genetics Consortium (AAGC); St Pourcain B, Smith GD, Henderson J, Kemp JP, Timpson NJ, Deloukas P, Ring SM, Wichmann HE, Muller-Nurasyid M, Novak N, Klopp N, Rodriguez E, McArdle W, Linneberg A, Menne T, Nohr EA, Hofman A, Uitterlinden AG, van Duijn CM, Rivadeneira F, de Jongste JC, van der Valk RJ, Wjst M, Jogi R, Geller F, Boyd HA, Murray JC, Kim C, Mentch F, March M, Mangino M, Spector TD, Bataille V, Pennell CE, Holt PG, Sly P, Tiesler CM, Thiering E, Illig T, Imboden M, Nystad W, Simpson A, Hottenga JJ, Postma D, Koppelman GH, Smit HA, Soderhall C, Chawes B, Kreiner-Moller E, Bisgaard H, Melen E, Boomsma DI, Custovic A, Jacobsson B, Probst-Hensch NM, Palmer LJ, Glass D, Hakonarson H, Melbye M, Jarvis DL, Jaddoe VW, Gieger C; Genetics of Overweight Young Adults (GOYA) Consortium; Strachan DP, Martin NG, Jarvelin MR, Heinrich J, Evans DM, Weidinger S; EArly Genetics & Lifecourse Epidemiology (EAGLE) Consortium. Meta-analysis of genome-wide association studies identifies three new risk loci for atopic dermatitis. Nat Genet. 2011 Dec 25;44(2):187-92. doi: 10.1038/ng.1017.
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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.
Shaun K Morris, MD, MPH principal investigator
The Hospital for Sick Children
Zulfiqar A. Bhutta, PhD, MBBS principal investigator
Aga Khan University and The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Mortality and Child Morbidity, run by The Hospital for Sick Children 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 1 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 25 Apr 2017. 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?
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?
Mortality within the first year of life (time frame: Day 3 of life, month 6 of life, month 12 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 NCT02233127, which also lists 5 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 25 Apr 2017.