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In response to COVID pandemic
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| Medical Research Council Unit, The Gambia | OTHER |
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The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates <2000g in a resource limited hospital setting.
This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates <2000g and aged <24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at <24h of admission) or standard care with continuous KMC at >24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.
Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early KMC | Experimental | Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home |
|
| Standard care | Active Comparator | Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Kangaroo Mother Care | Other | Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | All neonatal deaths within 28 postnatal days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Death | Time from start of intervention/control procedures to death | 28 days of age |
| Cardio-respiratory Stability | The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen C Brotherton, MBChB | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRC Unit The Gambia at LSHTM | Fajara | West Coast | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34401686 | Derived | Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, Darboe S, Jallow M, Ceesay B, Samateh AL, Tann CJ, Cousens S, Roca A, Lawn JE. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021 Aug 6;39:101050. doi: 10.1016/j.eclinm.2021.101050. eCollection 2021 Sep. | |
| 32143737 |
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Recruitment took place from 23rd May 2018 - 19th March 2020 at the neonatal unit of the only teaching hospital in The Gambia, providing WHO level 2+ newborn care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early KMC | Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission |
| FG001 | Standard Care | Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early KMC | Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality | All neonatal deaths within 28 postnatal days | All recruited neonates with primary outcome data at 28 days were included in the analysis. This consisted of all (n=138) neonates allocated to the intervention arm and 139 neonates in the control arm, as two control participants were lost to follow up. | Posted | Count of Participants | Participants | 28 days |
|
28 postnatal days
Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early KMC | Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Life threatening event | General disorders | Systematic Assessment | Defined as either apnoea needing resuscitation, severe instability as per protocol definitions or any other life threatening event as assessed by a clinician |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Helen Brotherton | London School of Hygiene & Tropical Medicine | 07481474150 | helen.brotherton@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2018 | Sep 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2020 | Sep 15, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007035 | Hypothermia |
| D003643 | Death |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Individually randomised controlled superiority trial
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| Standard care | Other | Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care |
|
| At 24 hours after start of intervention/control procedures |
| Number and Proportion of Participants With Hypothermia | Number and proportion of participants with hypothermia (Temperature <36.5 degrees Celsius) | At 24 hours after start of intervention/control procedures |
| Weight Gain | Average daily weight gain compared to admission weight | At 28 days of age |
| Exclusive Breastfeeding | Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation) | At time of hospital discharge, within study period, on average 2 weeks of age |
| Suspected Infection Between 3d to 28d of Age | Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up | Within 28 days of age |
| Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae | Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae | At day 28 of age |
| Duration of Hospital Admission | Mean length of admission (first admission only if re-admitted) | Within 28 days of age or at latest follow-up |
| Derived |
| Brotherton H, Gai A, Tann CJ, Samateh AL, Seale AC, Zaman SMA, Cousens S, Roca A, Lawn JE. Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC). Trials. 2020 Mar 6;21(1):247. doi: 10.1186/s13063-020-4149-y. |
| Standard Care |
Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | hours since delivery | Median | Inter-Quartile Range | hours |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Admission weight | Median | Inter-Quartile Range | grams |
|
| Admission weight <1200g | Count of Participants | Participants |
|
| Gestational age | Gestational age data available for only 271 due to death before assessment in 8 participants | Median | Inter-Quartile Range | weeks |
|
| Twin pregnancy | Count of Participants | Participants |
|
| Twin, both enrolled | Twin pairs in whom both were enrolled to the trial | Count of Participants | Participants |
|
| Stable at baseline | Stable condition defined as oxygen saturation more than or equal to 88% without supplementary oxygen and with normal respiratory rate and heart rate | Count of Participants | Participants |
|
Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care |
|
|
| Secondary | Time to Death | Time from start of intervention/control procedures to death | Posted | Median | Inter-Quartile Range | hours | 28 days of age |
|
|
|
| Secondary | Cardio-respiratory Stability | The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen. | Only neonates with outcome data available at 24h after enrolment were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality during first 24h of trial. | Posted | Median | Inter-Quartile Range | units on a scale | At 24 hours after start of intervention/control procedures |
|
|
|
| Secondary | Number and Proportion of Participants With Hypothermia | Number and proportion of participants with hypothermia (Temperature <36.5 degrees Celsius) | Only neonates with outcome data available at 24h after enrolment were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality during first 24h of trial. | Posted | Count of Participants | Participants | At 24 hours after start of intervention/control procedures |
|
|
|
| Secondary | Weight Gain | Average daily weight gain compared to admission weight | Only neonates with outcome data available at age 28d were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality, loss to follow up and small number of participants with missing data | Posted | Mean | Standard Deviation | grams/day | At 28 days of age |
|
|
|
| Secondary | Exclusive Breastfeeding | Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation) | Only neonates with outcome data available at discharge were included in the analysis, hence the number of participants analysed is less than 279. The missing data was principally due to mortality prior to discharge. | Posted | Count of Participants | Participants | At time of hospital discharge, within study period, on average 2 weeks of age |
|
|
|
| Secondary | Suspected Infection Between 3d to 28d of Age | Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up | All randomised participants were included in the analysis | Posted | Count of Participants | Participants | Within 28 days of age |
|
|
|
| Secondary | Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae | Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae | Not Posted | Apr 2030 | At day 28 of age | Participants |
| Secondary | Duration of Hospital Admission | Mean length of admission (first admission only if re-admitted) | Only neonates with outcome data available at time of discharge were included in the analysis, hence the number of participants analysed is less than 279. Neonates were died during first hospital admission were not included in the analysis. | Posted | Mean | Standard Deviation | Days | Within 28 days of age or at latest follow-up |
|
|
|
| 29 |
| 138 |
| 30 |
| 138 |
| 0 |
| 0 |
| EG001 | Standard Care | Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care | 34 | 141 | 28 | 141 | 0 | 0 |
|
| Risk of disability | Nervous system disorders | Systematic Assessment | Any condition placing the neonate at increased risk of permanent or temporary disability, such as suspected meningitis, severe jaundice or acquired hydrocephalus |
|
| Hospital re-admission | General disorders | Systematic Assessment | Re-admission within 28 postnatal days |
|
| Prolonged hospitalisation | General disorders | Systematic Assessment | Hospitalised for >28 days |
|
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| D000091642 | Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |