Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270823
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Brief Title:
Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion a Randomized Controlled Trial
Sponsor:
Kilimanjaro Clinical Research Institute
Organization:
Kilimanjaro Clinical Research Institute
Study Overview
Official Title:
Making Elective Caesarean Safer for Infants Lungs by Reducing Respiratory Distress Using Knee-chest-flexion a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid we could reduce the incidence of respiratory distress in term children born by planned CS
The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care
The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care
Detailed Description:
One of the major risk factors for termnear-term infants to develop respiratory distress RD is when they are born by elective caesarean section CS While this form of RD commonly diagnosed as transient tachypnea of the newborn TTN is considered to be self-limiting the severity of RD often leads to unexpected admission to the pediatric ward for respiratory support TTN has also been associated and asthma bronchiolitis and other wheezing syndromes later in life In low- and middle-income settings where neonatal intensive care resources are limited a considerable proportion of babies in need of respiratory support do not survive
There is now strong physiological evidence that RD after elective cesarean section is caused by this greater volume of airway liquid present at birth which is due to the absence of labor During labor uterine contractions contribute to the flexion of the fetus which increases abdominal and transpulmonary pressure This elevates the diaphragm resulting in lung liquid loss via nose and mouth Flexion induced by uterine contractions could be mimicked by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid When applying KCF we essentially bring the newborn back into fetal position similar to the holding position applied for performing lumbar puncture in neonates
If this simple intervention has shown to improve neonatal outcome in the clinical setting KCF will undoubtedly be an extremely cost-effective health care innovation The maneuver is easy-to-teach to any clinician performing cesarean section KCF will be performed conform standard gentle care and is likely to be entirely harmless These advantages easy-to-teach no cost no harm are relevant across all settings but may be particularly appealing in low-income settings where neonatal follow-up and access to neonatal intensive care are often either impossible or limited It is therefore of outmost importance to test this intervention in a larger institution adapted to performing high-quality clinical research in a low- or middle-income country
We now hypothesize that performing a knee-to-chest flexion performed directly after birth will reduce the incidence of respiratory distress in term children born by elective caesarean section
Objective To test whether performing a knee-to-chest flexion KCF manoeuvre directly after elective CS will decrease the incidence of respiratory distress in term infants when compared to standard care
Study design Single-center randomized controlled trial Study population Infants born by elective CS 37-42 weeks gestational age Simple randomization will be done to assign participants in either an interventional group or a control group Intervention As soon as the infant is out of the uterus a KCF is performed for 30 seconds while the infant remains attached to the cord Except for KCF the infant will receive normal routine care and there are no co-interventions
Control As soon as the infant is out of the uterus normal routine care is given
Study parameters The primary outcome is the occurrence of respiratory distress
Nature and extent of the burden and risks associated with participation benefit and group relatedness
In the group of term infants born after elective caesarean there is a 7 risk for respiratory distress of which 10 is complicated by PPHN Although KCF is a new intervention performed directly after birth for 30 seconds the technique used is similar to the way infants are held and positioned during a lumbar puncture As the infants in this study population are in good condition before birth and would otherwise also have been exposed to large intrathoracic pressures generated by uterine contractions during labor we expect that there is no added risk when the maneuver is performed gently and with care We recently demonstrated that performing KCF directly after birth is feasible and safe after elective CS As the percentages of elective CS are increasing worldwide both in developing and developed countries there is a large potential to reduce morbidity admissions at NICU and pediatric wards and healthcare costs in this group of infants
There is now strong physiological evidence that RD after elective cesarean section is caused by this greater volume of airway liquid present at birth which is due to the absence of labor During labor uterine contractions contribute to the flexion of the fetus which increases abdominal and transpulmonary pressure This elevates the diaphragm resulting in lung liquid loss via nose and mouth Flexion induced by uterine contractions could be mimicked by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid When applying KCF we essentially bring the newborn back into fetal position similar to the holding position applied for performing lumbar puncture in neonates
If this simple intervention has shown to improve neonatal outcome in the clinical setting KCF will undoubtedly be an extremely cost-effective health care innovation The maneuver is easy-to-teach to any clinician performing cesarean section KCF will be performed conform standard gentle care and is likely to be entirely harmless These advantages easy-to-teach no cost no harm are relevant across all settings but may be particularly appealing in low-income settings where neonatal follow-up and access to neonatal intensive care are often either impossible or limited It is therefore of outmost importance to test this intervention in a larger institution adapted to performing high-quality clinical research in a low- or middle-income country
We now hypothesize that performing a knee-to-chest flexion performed directly after birth will reduce the incidence of respiratory distress in term children born by elective caesarean section
Objective To test whether performing a knee-to-chest flexion KCF manoeuvre directly after elective CS will decrease the incidence of respiratory distress in term infants when compared to standard care
Study design Single-center randomized controlled trial Study population Infants born by elective CS 37-42 weeks gestational age Simple randomization will be done to assign participants in either an interventional group or a control group Intervention As soon as the infant is out of the uterus a KCF is performed for 30 seconds while the infant remains attached to the cord Except for KCF the infant will receive normal routine care and there are no co-interventions
Control As soon as the infant is out of the uterus normal routine care is given
Study parameters The primary outcome is the occurrence of respiratory distress
Nature and extent of the burden and risks associated with participation benefit and group relatedness
In the group of term infants born after elective caesarean there is a 7 risk for respiratory distress of which 10 is complicated by PPHN Although KCF is a new intervention performed directly after birth for 30 seconds the technique used is similar to the way infants are held and positioned during a lumbar puncture As the infants in this study population are in good condition before birth and would otherwise also have been exposed to large intrathoracic pressures generated by uterine contractions during labor we expect that there is no added risk when the maneuver is performed gently and with care We recently demonstrated that performing KCF directly after birth is feasible and safe after elective CS As the percentages of elective CS are increasing worldwide both in developing and developed countries there is a large potential to reduce morbidity admissions at NICU and pediatric wards and healthcare costs in this group of infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None