Serum Calcium ConcentrationNCT06573333
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
A study testing Umblical Cord Clamping in people with Serum Calcium Concentration, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
Trial summary
Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management. Read more about this study
- Who is it for?
- Ages 1 minute to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Serum Calcium Concentration
- What is being tested?
- Umblical Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Sep 2024
- 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 1 minute to 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
Who cannot join
- Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 45000
About this study
Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.
Objective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial
Read the detailed description
Place and Duration of Study: PEMH Rawalpindi and CMH Rawalpindi from January 2024 to July 2024.
Patients and Methods: Total sample size of 200 neonates will be included in the study divided into four groups with cord clamping at 15s, 30s, 60s, 120s each group will have a total of 50 neonates. Blood sampling for CBC / CRP / S. Electrolytes (Na, K, Total Ca, Ionized Ca, Mg), S Calcitonin, ABGs (HCO3 Levels) samples will be collected at 6 hours of life.
- Inclusion Criteria: Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
- Exclusion Criteria: Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
Expected Results: Research data on serum Calcium levels in neonates have shown no correlation to timing of cord clamping. Same results are expected in this study.
- Conditions
- Serum Calcium Concentration
- Being tested
- Umblical Cord Clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umblical Cord ClampingProcedure or surgery
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate
| Study group | Role | What they receive |
|---|---|---|
| 15 seconds | Experimental | Umbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life Receives: Procedure: Umblical Cord Clamping |
| 30seconds | Experimental | Umbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life Receives: Procedure: Umblical Cord Clamping |
| 60seconds | Experimental | Umbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life Receives: Procedure: Umblical Cord Clamping |
| 120 seconds | Experimental | Umbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life Receives: Procedure: Umblical Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Serum Calcium Levels
Measured: at 6 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum Calcium ConcentrationStudies 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
- Model description
- Randomised Controlled Trails
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umair Anees Qureshi, College of Physicians and Surgeons Pakistan
- Investigators
- Arshad Khushdil, MBBS, Principal investigator, Military Hospital Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573333
- Sponsor's protocol ID
- 369452
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
- ClinicalTrials.gov ID
- NCT06573333
- Acronym / sponsor ID
- 369452
- Conditions
- Serum Calcium Concentration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Aug 2024 (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.
Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.
Objective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial
Detailed description
Place and Duration of Study: PEMH Rawalpindi and CMH Rawalpindi from January 2024 to July 2024.
Patients and Methods: Total sample size of 200 neonates will be included in the study divided into four groups with cord clamping at 15s, 30s, 60s, 120s each group will have a total of 50 neonates. Blood sampling for CBC / CRP / S. Electrolytes (Na, K, Total Ca, Ionized Ca, Mg), S Calcitonin, ABGs (HCO3 Levels) samples will be collected at 6 hours of life.
- Inclusion Criteria: Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
- Exclusion Criteria: Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
Expected Results: Research data on serum Calcium levels in neonates have shown no correlation to timing of cord clamping. Same results are expected in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomised Controlled Trails
| Arm | Type | Receives |
|---|---|---|
| 15 seconds | Experimental | Procedure: Umblical Cord ClampingUmbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life |
| 30seconds | Experimental | Procedure: Umblical Cord ClampingUmbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life |
| 60seconds | Experimental | Procedure: Umblical Cord ClampingUmbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life |
| 120 seconds | Experimental | Procedure: Umblical Cord ClampingUmbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life |
Who may qualify
- Ages
- 1 minute to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
Key exclusion criteria (1 listed)
- Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
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 |
|---|---|---|
| Umblical Cord ClampingUmbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate | Procedure or surgery | 120 seconds, 15 seconds, 30seconds, 60seconds |
Primary outcome
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Time frame: at 6 hours of life
Serum Calcium Levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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.
Arshad Khushdil, MBBS principal investigator
Military Hospital Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umblical Cord Clamping in people with Serum Calcium Concentration, run by College of Physicians and Surgeons Pakistan 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 1 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 27 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umair Qureshi, MBBS (0519273480, umairanees94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates (time frame: at 6 hours of life). 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 27 Aug 2024.