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Stabiliziation of preterm infant with intact umbilical cord: a feasibility study

Stabilisation of preterm infants with intact umbilical cord, Aeration, Breathing, then Clamping: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON21731
Enrollment
15
Registered
2016-09-26
Start date
2016-09-26
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prematurity, resuscitation, cord clamping

Interventions

Preterm infants will be stabilized according to the Aearation, Breathing, then Clamping (ABC) approach. As soon as the infant is born, the infant will be placed on the Con-Cord table and respiratory s

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants of 26-35 weeks gestational age born vaginally and no other complications than preterm birth are expected and there are no signs of fetal distress. At this moment it is not possible to use the table in the OR, only vaginally born infants will be included

Exclusion criteria

Exclusion criteria: Signs of placental abruption or placenta praevia

Design outcomes

Primary

MeasureTime frame
After each infant the complete procedure, data and aspects of resuscitation will be evaluated. Any safety issues or problems with the SLT will first be resolved before the next infant will be included. We will evaluate the following items: The preterm infant -the platform can be placed close to the introïtus -the infant is placed on the table in the right position -the cord is not kinked or stretched -wrap is placed without a problem -time needed to start support < 90 seconds -oximetry probe can be placed by the nurse in a timely manner -respiratory support can be given in an adequate manner -no moderate to severe hypothermia at admission The neonatologist -can easily apply interventions to the infant -can easily reach for the dials of the ventilation device and oxygen blender -is able to read the monitor during the stabilization The neonatal nurse -is able to assist the neonatologist without obstruction The obstetrician -can assist birth of the preterm infant conform standard care -can unobstructed monitor the mother (and fetus number 2) -can monitor/assist in the third stage of labour conform standard care The obstetric nurse -is able to assist the neonatologist without obstruction The mother -can give birth to her baby in an unobstructive manner -can freely touch (and stimulate) her baby

Secondary

MeasureTime frame
Baseline characteristics: Gestational age, birth weight, sex, single or twin deliveries, monochorionic (with or without fetoscopic laser treatment) of dichorionic, IUGR (< 10th percentile birth weight)

Contacts

Public ContactArjan B. Pas, te

Leiden University Medical Center (LUMC), J6-S, Department of Pediatrics, P.O. Box 9600

a.b.te_pas@lumc.nl+31 (0)71 5262909

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)