Fetal DistressNCT03859037
Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
A study testing Umbilical cord milking in people with Fetal Distress, run by Ain Shams University.
Trial summary
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Fetal Distress
- What is being tested?
- Umbilical cord milking
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 10 Apr 2019
- 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 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- babies who need resuscitation
- Preterm babies with 28-34 weeks gestatinal age
Who cannot join
- preterm babies above 34 weeks gestational age, -- -
- refusal by mother or obestatracain, -- -babies with congenital anomalies
About this study
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not
Read the detailed description
Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.
- Conditions
- Fetal Distress
- Being tested
- Umbilical cord milking
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingOther
Also called Immediate cord claming
100 babies will have squeezing of blood from umbilical cord towards baby
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord milking | Experimental | One group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor Receives: Other: Umbilical cord milking |
| Immediate cord clamping | Placebo comparator | One group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor Receives: Other: Umbilical cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure mean blood pressure
Measure mean blood pressure in mmhg
Measured: Changes of all data will be assessed every 30seconds for ten minutes
Secondary outcomes (1)
Measure heart rate
Measure heart rate in beat/minutes
Measured: Heart rate will be assessed every 30 seconds for 10 minuets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Mar 2019 (estimated)
- Primary completion30 Mar 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups,one will have umbilical cord milking and other will have immediate cord clamping ,two groups will put on warmer after birth and blood pressure,heart rate ,oxygen saturation will be assessed by monitor every 30 seconds up to 10 minutes
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Elbeltagy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859037
- Sponsor's protocol ID
- AinshamsU12345
- Other IDs
- Aaaaaa
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
- ClinicalTrials.gov ID
- NCT03859037
- Acronym / sponsor ID
- AinshamsU12345
- Conditions
- Fetal Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 1 Mar 2019 (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.
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not
Detailed description
Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups,one will have umbilical cord milking and other will have immediate cord clamping ,two groups will put on warmer after birth and blood pressure,heart rate ,oxygen saturation will be assessed by monitor every 30 seconds up to 10 minutes
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord milking | Experimental | Other: Umbilical cord milkingOne group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor |
| Immediate cord clamping | Placebo comparator | Other: Umbilical cord milkingOne group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- babies who need resuscitation
- Preterm babies with 28-34 weeks gestatinal age
Key exclusion criteria (2 listed)
- preterm babies above 34 weeks gestational age, -- -
- refusal by mother or obestatracain, -- -babies with congenital anomalies
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 |
|---|---|---|
| Umbilical cord milkingAlso: Immediate cord claming100 babies will have squeezing of blood from umbilical cord towards baby | Other | Immediate cord clamping, Umbilical cord milking |
Primary outcome
measure mean blood pressure
Time frame: Changes of all data will be assessed every 30seconds for ten minutes
Measure mean blood pressure in mmhg
1 secondary outcome
Measure heart rate
Time frame: Heart rate will be assessed every 30 seconds for 10 minuets
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord milking in people with Fetal Distress, run by Ain Shams University.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
measure mean blood pressure (time frame: Changes of all data will be assessed every 30seconds for ten minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.