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Family nurture intervention (FNI) methods and treatment protocol of a randomized controlled trial in the NICU.doc

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Family nurture intervention (FNI) methods and treatment protocol of a randomized controlled trial in the NICU

Welchetal.BMCPediatrics2012,12:14 /1471-2431/12/14 STUDY PROTOCOL OpenAccess Familynurtureintervention(FNI):methodsand treatmentprotocolofarandomizedcontrolled trialintheNICU MarthaGWelch1,2,3*,MyronAHofer1,SusanABrunelli1,RaymondIStark2,HowardFAndrews4,JudyAustin4and MichaelMMyers1,2,5,fortheFamilyNurtureIntervention(FNI)TrialGroup1,2,5,6 Abstract Background:Thestressthatresultsfrompretermbirth,requisiteacutecareandprolongedphysicalseparationin theNeonatalIntensiveCareUnit(NICU)canhaveadversephysiological/psychologicaleffectsonboththeinfant andthemother.Inparticular,theexperiencecompromisestheestablishmentandmaintenanceofoptimalmother- infantrelationship,thesubsequentdevelopmentoftheinfant,andthemother’semotionalwell-being.These findingshighlighttheimportanceofinvestigatingearlyinterventionsthataredesignedtoovercomeorreducethe effectsoftheseenvironmentalinsultsandchallenges. Methods:Thisstudyisarandomizedcontrolledtrial(RCT)withblindedassessmentcomparingStandardCare(SC) withanovelFamilyNurtureIntervention(FNI).FNItargetspreterminfantsborn26-34weekspostmenstrualage (PMA)andtheirmothersintheNICU.Theinterventionincorporateselementsofmother-infantinterventionswith knownefficacyandorganizesthemunderanewtheoreticalcontextreferredtocollectivelyascalmingactivities. ThisinterventionisfacilitatedbyspeciallytrainedNurtureSpecialistsinthreeways:1)Intheisolettethrough calminginteractionsbetweenmotherandinfantviaodorexchange,firmsustainedtouchandvocalsoothing,and eyecontact;2)OutsidetheisoletteduringholdingandfeedingviatheCalmingCycle;and3)throughfamily sessionsdesignedtoengagehelpandsupportthemother.Inconcertwithinfantneurobehavioraland physiologicalassessmentsfrombirththrough24monthscorrectedage(CA),maternalassessmentsaremadeusing standardtoolsincludinganxiety,depression,attachment,supportsystems,temperamentaswellasphysiological stressparameters.Qualityofmother-infantinteractionisalsoassessed.Ourprojectedenrolmentis260families(130 pergroup). Discussion:TheFNIisdesignedtoincr