Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section

Premature Infant Clinical Trial

Official title:

Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187510
• Other study ID #: CSPTNeonat2014_01
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: April 27, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Preterm infants less than 34 weeks' gestation born by cesarean section

Exclusion Criteria:

• Inability to obtain informed consent from the mother state

• Monochorionic-monoamniotic twin gestation

• Placenta abruption

• Uterine rupture

• Transplacental cesarean

• Hydrops fetalis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delayed Clamping
• Milking
• Premature Infant
• Umbilical Cord

Intervention

Procedure:
• Umbilical cord milking
Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
• Delayed cord clamping
Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.

Locations

Country	Name	City	State
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin	g/dl	1 hour and 24 hours at born	No
Secondary	Apgar Score	Basic score to mesure the newborn status. From 0 to 10.	1 and 5 minutes	No
Secondary	Arterial pressure	Mean of systolic and dyastolic arterial pressure in mm Hg	2, 6, 12, 24, 36 and 48 hours of life	No
Secondary	Orine volume	Total volume of orine at 24 and 48 hours of life. Total ml.	24 and 48 hours of life	No
Secondary	Use of vasopresors drugs	To use or not to use the vasopresors drugs during the first 24 hours of life	24 hours of life	No
Secondary	Number of concentrate hematies transfusion	Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.	participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)	No
Secondary	Intraventricular hemorrhage	Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile	participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)	No
Secondary	Bronchopulmonary dysplasia	Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)	participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)	No
Secondary	Total intensive care unit stay	Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.	Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)	No
Secondary	Hematocrit	In percentage	1 hour and 24 hours at born	No