Clinical trial NCT04070560: Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
Official title: SAVE (Sustained Cord Circulation Awaiting VEntilation)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asphyxia Neonatorum
Resuscitation
Keywords: umbilical cord
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2019-08-28
Enrollment: 600
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.

Detailed description: The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.

It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.

Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.

Eligibility criteria: Inclusion Criteria:

* Pregnancy week ≥35 + 0
* Singletons
* Expected vaginal delivery
* The woman / couple can adequately assimilate information about the study
* Signed informed consent of both prospective parents

Exclusion Criteria:

* Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
* The child is born via acute caesarean section after inclusion and opening of study envelope
* placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)

Primary outcomes:
measure: Apgar score
timeFrame: At 5 minutes after birth
Secondary outcomes:
measure: Apgar score
timeFrame: At 1 minute after birth
measure: Apgar score
timeFrame: At 10 minute after birth
measure: Time of first cry or breathing effort
timeFrame: Within 10 minutes after birth
measure: Time of establishing spontaneous breathing
timeFrame: Within 10 minutes after birth
measure: Presence at one day of age
timeFrame: 24 hours
measure: Need of neonatal intensive care
timeFrame: 7 days
measure: Score for Neonatal Acute Physiology (SNAP-II)
timeFrame: 7 days
measure: Morbidity Assessment Index for Newborns (MAIN)
timeFrame: 7 days
measure: Blood glucose
timeFrame: 4 hours after birth
measure: Breathing difficulties
timeFrame: 1 hours after birth
measure: Breathing difficulties
timeFrame: 6 hours after birth
measure: Mortality
timeFrame: One year
measure: Development
timeFrame: 12 months
measure: Development
timeFrame: 24 months
measure: Autism
timeFrame: 24 months
measure: Development
timeFrame: 54 months
measure: Motor development
timeFrame: 54 months
Other outcomes:
measure: Thompson score
timeFrame: 1 hour after birth
measure: Thompson score
timeFrame: 6 hours after birth
measure: Thompson score
timeFrame: 12 hours after birth
measure: Thompson score
timeFrame: 24 hours after birth
measure: Thompson score
timeFrame: 48 hours after birth
Locations:
city: Halmstad
country: Sweden
facility: Hospital of Halland
state: Halland
city: Malmö
country: Sweden
facility: Skåne University Hospital
state: Skåne
city: Ystad
country: Sweden
facility: Ystad hospital
Study officials:
affiliation: Lunds University/Skåne University Hospital
name: Ola Andersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.
citation: Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
citation: Katheria AC. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children (Basel). 2019 Apr 22;6(4):60. doi: 10.3390/children6040060.
citation: Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.
citation: Ekelof K, Saether E, Santesson A, Wilander M, Patriksson K, Hesselman S, Thies-Lagergren L, Rabe H, Andersson O. A hybrid type I, multi-center randomized controlled trial to study the implementation of a method for Sustained cord circulation And VEntilation (the SAVE-method) of late preterm and term neonates: a study protocol. BMC Pregnancy Childbirth. 2022 Jul 26;22(1):593. doi: 10.1186/s12884-022-04915-5.
citation: Wilander M, Sandblom J, Thies-Lagergren L, Andersson O, Svedenkrans J. Bilirubin Levels in Neonates >/=35 Weeks of Gestation Receiving Delayed Cord Clamping for an Extended Time-An Observational Study. J Pediatr. 2023 Jun;257:113326. doi: 10.1016/j.jpeds.2023.01.005. Epub 2023 Jan 14.