NCT03859037

Brief Summary

Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

29 days

First QC Date

February 11, 2019

Last Update Submit

February 27, 2019

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

  • measure mean blood pressure

    Measure mean blood pressure in mmhg

    Changes of all data will be assessed every 30seconds for ten minutes

Secondary Outcomes (1)

  • Measure heart rate

    Heart rate will be assessed every 30 seconds for 10 minuets

Study Arms (2)

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

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

Other: Umbilical cord milking

Interventions

Umbilical cord milkingOTHER

100 babies will have squeezing of blood from umbilical cord towards baby

Also known as: Immediate cord claming
Immediate cord clampingUmbilical cord milking

Eligibility Criteria

Age28 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • babies who need resuscitation
  • Preterm babies with 28-34 weeks gestatinal age

You may not qualify if:

  • preterm babies above 34 weeks gestational age, -- -
  • refusal by mother or obestatracain, -- -babies with congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Distress

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 11, 2019

First Posted

March 1, 2019

Study Start

March 1, 2019

Primary Completion

March 30, 2019

Study Completion

April 10, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02