Starting respiratory support prior to cord clamping in preterm infants to improve pulmonary en circulatory transition immediately after birth: effectivenss study.

Stabilisation of preterm infants with intact umbilical cord: effectiveness study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19967

Enrollment

Registered

2018-04-20

Start date

2018-04-24

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Preterm infants, transition, resuscitation, cord clamping. Premature kinderen, transitie, resuscitatie, afklemmen navelstreng.

Interventions

Preterm infants randomized to the intervention group will be stabilized according to physioloigcal based coord clamping (PBCC). As soon as the infant is born, the infant will be placed on the Concord

Eligibility

Inclusion criteria

Inclusion criteria: Infants born between 24 and 31 weeks of gestational age and no other complications than preterm birth are expected.

Exclusion criteria

Exclusion criteria: Significant congenital malformations influencing cardiopulmonary transition. Signs of placental abruption or placenta praevia. Signs of severe fetal distress. Emergency caesarean section (ordered to be executed within 15 minutes).

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the time needed to stabilise the infant, starting from birth and defined as the establishment of regular spontaneous breathing evaluated on the respiratory function monitor, a heart rate ≥ 100 bpm and oxygen saturation above 90% while using FiO2 < 0.40.	—

Secondary

Measure	Time frame
The time point after birth when respiratory support was started and oximeter signals could be interpreted. The occurrence the ABC approach could not be performed and reason why. Failure of reaching the primary outcome within 10 minutes from birth. Duration of mask ventilation given. Average pressures given during mask ventilation. Average pressure given during mask CPAP. Oxygen saturation and heart rate in the first 10 minutes from birth. Time point of cord clamping. Problems occurring with the cord before cord clamping. Occurrence of the need for cord clamping before stabilisation. The occurrence of the necessity for intubation in the DR. The occurrence of hypothermia at admission in the NICU. Apgar scores. Echocardiography measurement: ductal flow ratio at 1 hour of age. Maternal blood loss. The occurrence of postpartum haemorrhage. The occurrence of surgical site wound infection after caesarean section.	—

Measure

Time frame

The time point after birth when respiratory support was started and oximeter signals could be interpreted. The occurrence the ABC approach could not be performed and reason why. Failure of reaching the primary outcome within 10 minutes from birth. Duration of mask ventilation given. Average pressures given during mask ventilation. Average pressure given during mask CPAP. Oxygen saturation and heart rate in the first 10 minutes from birth. Time point of cord clamping. Problems occurring with the cord before cord clamping. Occurrence of the need for cord clamping before stabilisation. The occurrence of the necessity for intubation in the DR. The occurrence of hypothermia at admission in the NICU. Apgar scores. Echocardiography measurement: ductal flow ratio at 1 hour of age. Maternal blood loss. The occurrence of postpartum haemorrhage. The occurrence of surgical site wound infection after caesarean section.

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Contacts

Public ContactRonny Knol

r.knol@erasmusmc.nl+31 10 7036077

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)