Neonatal Resuscitation With Intact Cord

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.

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Detailed Description

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Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will receive routine care PLUS administration of CPAP and if need positive pressure ventilation. The outcome is to determine whether the addition of ventilation provides a larger placental transfusion and a smoother transition at birth.

Conditions

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Intraventricular Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Ventilation during DCC (V-DCC)

Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)

Group Type ACTIVE_COMPARATOR

V-DCC

Intervention Type PROCEDURE

Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds

DCC plus dry and stimulate

Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)

Group Type ACTIVE_COMPARATOR

Delayed cord clamping

Intervention Type PROCEDURE

Delayed clamping of the umbilical cord for 60 seconds

Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels

Intervention Type PROCEDURE

Interventions

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V-DCC

Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds

Intervention Type PROCEDURE

Delayed cord clamping

Delayed clamping of the umbilical cord for 60 seconds

Intervention Type PROCEDURE

Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)

Exclusion Criteria

* Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
* Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
* Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
* Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
* Placenta Accreta
* Prolonged premature rupture of membranes (\> 2 weeks) prior to 23 weeks gestation

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

31 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No