Plain English Summary
Background and study aims
This is a new maneuver designed to improve the respiratory outcome of the newborns delivered by caesarian section. The idea is simple; the researcher suggests a maneuver through artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible.
Who can participate?
Term and near term babies ( > 35 weeks gestational age)
What does the study involve?
This is a new maneuver designed to improve the respiratory outcome of the newborns delivered by caesarian section. It involves artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible. The maneuver will be trialled on term and near term babies ( > 35 weeks gestational age) from the three participating centres throughout the study period.
What are the possible benefits and risks of participating?
The technique of this maneuver is important that it should be done with repetitive gentle compression of both sides of the chest; too little compression is of no benefit; whereas too much compression may cause fracture of the ribs and cardiac arrhythmias.
Where is the study run from?
1. Al-Batool Teaching Hospital, Mosul
2. Al-Khansa teaching hospital, Mosul
3. Nineveh private hospital, Mosul
When is the study starting and how long is it expected to run for?
February 2018 to December 2018
Who is funding the study?
Nenavah health office, Mosul, Iraq
Who is the main contact?
Dr Mohammed Hamid Al-sabawi
mhmmdalsabawi2@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Mohammed Hamid Al-sabawi
ORCID ID
http://orcid.org/0000-0001-6950-9444
Contact details
Ibn Sena Teaching Hospital
Mosul
41001
Iraq
+9647701607988
mhmmdalsabawi2@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A new maneuver for initial resuscitation of newborns after Caesarean delivery
Acronym
Study hypothesis
This study is designed to improve the respiratory outcome of the newborn delivered by caesarean section and to decrease the incidence and duration of transient tachypnea among these newborns due to wet lung syndrome.
Ethics approval
Not provided at time of registration
Study design
interventional case-control study
Primary study design
Interventional
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available.
Condition
Transient tachypnea of newborns
Intervention
The researcher suggests a maneuver through gentle artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible. This "Mohammed's maneuver" is done by upside-down position of the baby then gentle compression on the lateral sides of the chest of newborn for several times either by one or both hands of the obstetrician while the assistant is carrying the newborn or by carrying of the newborn by one hand of the obstetrician and compression of the chest by the other hand. It is preferably accompanied by suction of fluid from nose and mouth of newborn. This maneuver is safe and should not takes >30 seconds. The pressure of compression should be neither be too little or too severe.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Respiratory outcome of the newborns delivered by caesarian section measured using APGAR score assessed at 1, 5, 10, 15, and 20 min after birth.
Secondary outcome measures
The length of time the newborn displays transient tachypnea following birth.
Overall trial start date
01/01/2010
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Term and near term babies ( > 35 weeks gestational age)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Preterm (< 35 weeks gestation) neonates
Recruitment start date
01/02/2010
Recruitment end date
10/12/2018
Locations
Countries of recruitment
Iraq
Trial participating centre
Al-Batool Teaching Hospital (Gynaecology And Obstetrics)
Nenaveh
Mosul
14004
Iraq
Trial participating centre
Al-Khansa teaching hospital
Nenaveh
Mosul
14004
Iraq
Trial participating centre
Nineveh private hospital
Nenaveh
Mosul
14004
Iraq
Sponsor information
Organisation
Nineveh Health Directorate Training Center & Human Development
Sponsor details
Nineveh
Mosul
41001
Iraq
+9647701736208
mslhrtdc@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Nenavah health office
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed neonatal journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request and will be included in the subsequent results publication.
Intention to publish date
10/03/2019
Participant level data
Available on request
Basic results (scientific)
On studying of 500 babies (250 cases & 250 control) delivered by caesarian section. The 250 cases who undergo this new maneuver, majority of them (196) or (78.4%) have been received little or no further resuscitation (i.e. just the routine care e.g. suction and oxygen therapy); whereas the minority of cases (54) or (21.6%) required further resuscitation and interventions (e.g. ambu bag, nasal cannula/CPAP, endotracheal intubation and cardiac compression, or drugs e.g. adrenaline).
The 250 control who didn't undergo this maneuver, (123) or (49.2%) require little or no further resuscitation; whereas the other (127) or (50.8%) were require further resuscitation and interventions.
The duration of transient tachypnea also significantly decreased among most newborns cases from few to several hours in comparison with those controls that last longer.
Publication list