APPENDIX A: SHORT INFORMATION LEAFLET – ORAL ASSENT

[TO BE PRINTED ONTRUSTHEADED PAPER]

CordPilotTrial

Parents’InformationLeafletforVerbalConsent

Weareinviting youtotakepart in our researchstudy because yourdoctors thinkyouwillgivebirthmorethaneightweeks beforeyour duedate(verypreterm). Babiesbornatthistimeare veryprematureandneedhelpwithbreathing,feedingand keeping warm.Wewant totryto improve thefuture careofmothers andbabiesborn verypremature.

What isthe purposeofthe study?

Usuallyat thebirthof aprematurebaby,theumbilical cord is clampedandcutstraightaway,the babyis placed ina plasticwrap toretain heat,andthencared for bytheneonatologist (a doctoror nursewho is aspecialist in thecareofnewborn babies) onaspecial table,which isusually at the sideofthe room. Clamping thecord stopsbloodflowbetweentheplacenta andthebaby. Ifthecord is notclampedstraightaway, this bloodflowmaycontinuefor several minutes, potentiallytransferringbloodfromtheplacentatothebaby.Waitinga fewminutes beforeclamping the cordmayhelpthebabyadjust tolifeoutsidethewomb. As we do notknowwhenthebesttime istoclampthe cordfor verypretermbirths, we aredoingthis study.

What isthe study?

For babiesbornverypreterm, wewant to compare (1)waiting forat leasttwo minutesbeforecord clamping (deferred cord clamping) with(2) clampingthecordbefore20seconds. Fordeferredcord clamping, careforthebabywill be providedatthebedside.Ifthe cord is clampedbefore20seconds,theneonatalteamwill choose whether carefor thebabyis providedatthe bedside orat thesideofthe room.In bothcasesthebaby willreceive the samecare at birth,just indifferentplaces.

DoI have to take part?

It is upto youto decideifyouwanttojoin thestudyor not.Ifyouagree totakepart,youarefreeto withdrawatanytime, withoutgivingareason.Ifyouchoosenot to takepart,your care willcontinuein thenormalway, andyou andyourclinician can decidewhentoclampthecord.

Whatwill I have to do?

Weareinviting you togive verbal consentnow totake part in thestudy.Ifyouagreetotakepart inthestudy,thenat thebirthyouwillhaveeither(1) cord clampingafteratleast twominutes, or(2) cord clampingwithin20seconds.Ifthecord is clampedafterat least 2minutes,careforyourbabywill be provided at yourbedside.Ifthe cordisclampedbefore20seconds,theneonatalteamwill choose whethercareforyourbabyisprovided at yourbedside orat thesideoftheroom.Ifyoudo takepart,wewill ask you tosign aconsentformbeforeyougohomeafterthebirth.

Wewillsendyousome short questionnairetocomplete at varioustimesafter thebirth,andwewouldlike to findouthowyourchild is doingat aroundtwoyearsofage.

Who hasreviewed the study?

This studyhasbeenreviewed and givenfavourableopinion byNottingham 2ResearchEthics Committee(REC), theNottinghamUniversityHospitals NHSTrust,andtheNationalInstitute ofHealthResearchProgrammeforAppliedResearch(whichfundedthestudy).

Thankyoufor reading thisinformationsheet

APPENDIX B: LONG INFORMATION LEAFLET

[TO BE PRINTED ONTRUSTHEADED PAPER]

CordPilotTrialParents’InformationLeaflet

What isthe purposeofthe study?

Inthe UKonein every 70 babies isborn morethaneightweeksbefore their duedate(verypreterm).Theseveryprematurebabieshaveimmaturelungs, andoftenwill need helpwithbreathing,feeding andkeeping warm. Usuallyatthe birthof aprematurebaby, theumbilical cord isclampedandcutstraightaway, the baby is placedin aplastic wrap toretain heat,andthencared forbytheneonatologist(adoctor or nursewho is aspecialistinthe careofnewbornbabies)ona specialtable,which is usuallyat the sideofthe room.

Clamping the cordstops bloodflowbetweentheplacenta andthebaby.Ifthe cordis notclampedstraightaway,thisbloodflowmaycontinueforseveral minutes, potentiallytransferringblood from theplacenta tothebaby.

Evidencefromprevious researchsuggeststhatwaiting afewminutes before clamping thecord mayhelp thebabyto adjusttolifeoutsidethewomb.However,this researchwas notofhighenoughquality, andthestudiesweretoosmall,togive aclearanswer. The researchsuggestedthatfewer babiesneeded bloodtransfusionsforanaemia,and theriskofbleedinginthebrainandtheriskofa severeinfectionofthebowelwere reduced.However,noneofthesebabieshave beencontacted inchildhoodtofind outhowtheyare doing.

As we do notknowwhen thebesttime is toclampthe cordfor very pretermbirths, we aredoing this study. For babiesbornverypreterm, wewant tocomparewaiting foratleasttwominutes before cord clamping(deferredcordclamping) withclampingthe cord before20seconds. Fordeferredcord clamping, careforthebabywill be providedatthebedside.Ifthe cord is clampedbefore20seconds,theneonatalteamwill choose whether carefor thebabyis providedatthe bedside orat thesideofthe room.Inbothcasesthebabywillreceive the samecareat birth,just indifferentplaces.

This studywill help ustodecidewhenthebest timeis toclampthecordfor verypretermbirths.

Whyhave I been invited?

Youhavebeeninvitedtoparticipate in thisstudy as your doctors thinkyou maygivebirthtoyour babymorethaneightweeks beforeyour duedate.

DoI have to take part?

It isfor youtodecideifyouwanttojointhestudy or not.Ifyouagree totakepart,youarefree towithdrawat anytime,withoutgiving areason.This will not affectthestandardof careyouandyourbaby receive.Ifyouchoosenot to takepart,your care will continue inthenormalway, and youandyourcliniciancandecidewhentoclampthecord.

Whatwill I have to do?

Youwill be askedtosignaconsentformbeforeyouparticipate inthestudy.If thebirthhappensquicklyandthere isnotenough timefor you tosigntheform,youmaybe askedtogiveverbalconsent.Ifyougiveverbal consent, then beforeyouleavehospitalyouwill beaskedtosignaconsent formto allowusto accessyourhospital records, and tocontact youlater to findouthowyouandyourbabyare.

If youtakepart in thestudy,thenatthebirthyouwillhave either (1) cord clamping after atleasttwominutes, or (2) cord clampingbefore20seconds.The decisionaboutwhichyoureceivewill be decided bychance (rather liketossingacoin)andneitheryounoryourdoctor will be abletochoose.This is important, asit ensuresafairtestbetweenthetwodifferent formsofcare. Ifthecord is clampedafter atleast 2minutes, careforyour babywillbe providedatyourbedside.Ifthecord is clampedbefore20seconds,theneonatalteamwill choose whethercareforyourbabyis providedatyourbedside orat thesideoftheroom.

Wewill ask youtocomplete a shortquestionnairetwo–threemonthsafterthebirth, andanotheratoneyearafter thebirth.Thesewillusuallybe posted toyou athome,with aFreepostreturnenvelope,but ifyour babyis in hospitalat sixweeksyou maybegiventhequestionnairethereinstead. Completing eachquestionnaire takesabout15 minutes.

We willwritetoyouagainwhenyourchild isaroundtwoyearsofageto findouthowyourchild is doing.Wewill post you aquestionnairewhichwill take around10–15minutestocomplete.Thequestionnairewill be postedto you at yourhome,with aFreepost returnenvelope.Wemaycontact youagainin thefuturetofind outhowyour childis doing.

Tohelpusstayin touchwithyou and yourchildand tofindouthowyou are, wewillaskyourpermission toregisteryouandyourchildwith theNHSInformationCentre.

What are the possibledisadvantages andrisksof taking part?

Inthepast,a disadvantageofdeferring cordclampingfor verypreterm births wasthoughttobethat it woulddelaythe neonatologistproviding carefor thebaby. But theneonatologists are nowable toprovidecareforthebabyat the mother’sbedside.Thereforecarefor thesebabieswill be thesame, regardlessofwhenthecordis clamped.

What are the possiblebenefits of takingpart?

Wecannotpromisethestudywill helpyou or your babybuttheinformationwegetfromthisstudywill helptoimprove thefuture careof mothersand babiesborn verypremature.

What happenswhentheresearchstudystops?

Wewillwriteto you at theendofthestudy,andexplainthatwewill send youa summaryofthe studyresults unlessyou ask usnotto.Ifyoudecide nottotakepart in thefollowupassessment,wewill use thedatacollecteduptothatpoint,unlessyouaskusnotto.

If theevidenceshowsthatthere isan importantdifferencebetweenthetwoformsof care,then we maywant tocontactyouagaininthefuturetofindouthowyourchild is.

Willmytaking part in thisstudybe kept confidential?

Yes.All information we collect aboutyouwillbe kept inthestrictestconfidence. Inorder tobe ableto contactyouaboutyourownandyourbaby’shealth,yournameandcontactdetails will be madeavailabletotheresearchersrunning this studyandheldattheco-ordinatingcentre in Nottingham,andnot just heldby yourlocalstudydoctor.Thesedetaiwillbe kept securely,withaccessrestricted.Youwill not benamedorotherwiseidentified inanystudypublication.

Involvement ofyourGeneralPractitioner(GP)

Wewillwritetoyour GPto explainthatyouare taking part in thestudy.Wemaycontactyour GP if we lose contact withyou,for instancebecauseyoumove, unless youask usnotto.

Whatwill happento theresults of theresearchstudy?

Thefindingsfrom thisinitial(pilot) studywill beusedtoplanthelargerstudy.Theywill alsobepresentedatmedicalmeetingsandsubmittedfor publication inmedicaljournalsandnewsletters.Wewill send youupdatesontheresearchandasummaryofthestudyresultsunless you askusnotto.

What if thereisa problem, or Iwant independentadvice?

If youhave a concern or questions aboutanyaspectof this study,youshouldask tospeaktothelocalresearchers(theircontactdetailsare attheendof this leaflet).YoucanalsocontacttheTrialCo-ordinatingCentreattheNottinghamClinicalTrials Unit.

If youwant totalk to someoneelseyoucancontactthehospital’sPatientAdvisoryandLiaisonService(PALS).Theywill be ableto giveyouadviceabouthowto contact someonefor independentadvice. Ask oneofthedoctors or nurseshowto contactthem.

If youwish tomakea complaint,or haveanyconcernsaboutanyaspectofyour careduringthe courseofthestudy, thenormalNHScomplaintsservice is available to you.Ifyouareharmedbytakingpart in this study,there areno specialcompensationarrangements.Ifyouare harmedduetosomeone’snegligence,thenyoumayhavegroundsfor legalactionbutyoumayhave topayforthis

Who hasreviewed the study?

This studyhasbeenreviewed and givenfavourableopinion byNottingham 2ResearchEthics Committee(REC).TheREC looksafter the rights,well beinganddignityofpeopleinvited to takepart inresearchstudies.Thestudyhasalso beenreviewedbytheNottinghamUniversity Hospitals NHSTrust,andtheNationalInstituteofHealthResearchProgrammeforAppliedResearch(which hasfundedthe study).

Furtherinformationandcontactdetails

Further information isavailable on

Contactdetails ofyour local researchteam

Name:

Telephone:

Alternatively, contactthestudyteamat theNottinghamClinical Trials Unit:

AngelaPushpa-Rajah,Cord Pilot Trial

NottinghamClinicalTrials Unit, NottinghamHealthSciencePartnersC Floor,South Block,QueensMedicalCentre

NottinghamNG72UH

Tel:01158844936Email:

APPENDIX C: INTERVIEW SCHEDULE

Opening questions

1)Please can you describe what led up to your baby’s birth?

2)What can you remember about being in the trial?

Experience of the recruitment process

  • Please can you tell me what happened when you were approached about going into the trial?
  • What can you remember being told or reading about the trial?
  • Had you heard of the trial before?
  • Were you clear about what being in the trial would mean for you and your baby?
  • Can you tell me about what happened when you agreed to take part in the trial?
  • How did it feel at the time?
  • To what extent did you feel it was your decision?
  • Did you feel, at that time, that you were able to make that decision?

.i.Did you have enough information?

.ii.Did you have enough time to make the decision?

  • Did you feel that you could say no if you wanted to?
  • Did you feel you could change your mind if you wanted to?
  • What were your reasons for agreeing to take part in the trial?
  • Were you clear about what was going to happen to you and your baby/had happened to you and your baby as part of the Cord Pilot Trial?
  • [for women who gave oral assent] How did you feel about getting some information about the trial before the birth, and then having more information and time to discuss the trial after your baby was born?
  • Was there anything about being invited into the trial and agreeing to take part that you felt particularly comfortable with or liked?
  • Was there anything about being invited into the trial and agreeing to take part that you were particularly unhappy with, or disliked?
  • Was there anything that could have been done differently to improve the way you were invited into the trial?

Additional Question

  • Have you been involved with/participated in any other research trials?

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