Asphyxia Neonatorum, Resuscitation
Conditions
Keywords
umbilical cord
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.
Interventions
PROCEDUREIntact cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
PROCEDUREEarly (≤ 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Sponsors
Skane University Hospital
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Weeks to 42 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | At 5 minutes after birth | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | At 1 minute after birth | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia. |
| Time of first cry or breathing effort | Within 10 minutes after birth | Assessed by staff present |
| Time of establishing spontaneous breathing | Within 10 minutes after birth | Assessed by staff present |
| Presence at one day of age | 24 hours | The place of stay for newborn at one day of age |
| Need of neonatal intensive care | 7 days | Admission to neonatal intensive care unit |
| Score for Neonatal Acute Physiology (SNAP-II) | 7 days | Assessed by staff at neonatal intensive care unit |
| Blood glucose | 4 hours after birth | Sampled by staff at nursery of neonatal intensive care |
| Breathing difficulties | 1 hours after birth | Respiratory rate \> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care |
| Mortality | One year | Death after birth |
| Development | 12 months | Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. |
| Autism | 24 months | Screening by Modified Checklist for Autism in Toddlers (M-CHAT). 20-question test. Answers yes or no. A total score of 2 and below on the first part of the M-CHAT indicate low autism risk, a total score of 3-7 indicates medium risk and prompts administration of the follow-up form. A total score of 8 or higher indicates high autism risk. |
| Motor development | 54 months | Assessed by Movement Assessment Battery for Children (ABC). The test contains 8 tasks covering the following 3 areas: Manual Dexterity, Ball Skills, Static and Dynamic Balance. Standard scores for each domain can be compared to normative data and interpreted in terms of percentile equivalents (a) ≤5th percentile reflecting definite motor impairment, (b) ≤15th percentile reflecting borderline motor impairment, or (c) \>15th percentile reflecting no motor impairment. |
| Morbidity Assessment Index for Newborns (MAIN) | 7 days | Assessed by staff at neonatal intensive care unit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thompson score | 1 hour after birth | Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes. |
Countries
Sweden
Outcome results
None listed