Score card based systematic risk assessment will be performed with the 'R4U' score card at the first antenatal booking visit followed by (provided that informed consent is given), if necessary, a specific referral to, e.g. a higher level obstetric care (gynaecologist), or psychosocial care in case of medical or non-medical high risk using risk-specific care pathways.
If consent is given, and providing no contra-indications occur, the baby should then be randomised between 20 and 48 hours of age.
Provided that consent was given, children were individually randomized into either the SP or the placebo group in a 1∶1 ratio at the time of admission, using permuted blocks of 12 generated by computer using the STATA program.
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2474/15/133/prepub wouldulikeike to thank the radiology institutes of Dr. Doringer and Dr. Kubin to put the radiographic images at the author´s disposal, provided patients consent was given.
All students who agreed to participate and provided written informed consent were given questionnaires; all incomplete questionnaires were not included.
All patients who attended the CR programme were considered eligible to participate, provided that written consent was given.
Written informed consent was provided by all participants, and consent was given by the parents for infants to participate in the study.
Patients with a positive pLDH-based RDT were included in the trial, provided that full written informed consent was given by the patient or carer.
After a written informed consent was given, each individual provided a one-time 30-ml blood sample collected in heparinized tubes.
Written consent was given after both verbal and written information was provided.
All patients provided informed consent prior to enrollment, and "enrollment" was defined as the date consent was given.
