Neonatal Resuscitation With Intact Cord (NRIC)

Sharp HealthCare

Status: Completed

Conditions: Intraventricular Hemorrhage

Treatments: Procedure: Delayed cord clamping; Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels; Procedure: V-DCC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02231411

5R21HD080594 (U.S. NIH Grant/Contract)

NRIC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 23 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Ventilation during DCC (V-DCC)

Active Comparator group

Description:

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)

Treatment:

Procedure: V-DCC

DCC plus dry and stimulate

Active Comparator group

Description:

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)

Treatment:

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

Procedure: Delayed cord clamping