The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
24. august 2026 opdateret af: Carissa Gasparovic, University of Texas Southwestern Medical Center
The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and following discharge. The specific aims are:
Aim 1: To evaluate the primary outcome of infant physiological response, including heart rate, respiratory rate, and oxygen saturation, when read by their caregiver. Infant heart rate, respiratory rate and oxygen saturations (SpO2) will be measured 15 minutes prior to the intervention, at start of the intervention, 2 minutes into the intervention, and 15 minutes after the intervention is completed. Outcomes will be compared to those of a control group.
Aim 2: To explore the secondary outcome of the intervention effect on maternal mental health, as measured by changes in postpartum depression (PPD) scores.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
120
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- the infant must have a NICU LOS > 3 days;
- a dedicated caregiver, such as parent, relative, friend of the family, grandparent are present in NICU;
- the primary caregiver can read and speak in English.
Exclusion Criteria:
- Infants with a confirmed diagnosis of hearing loss will be excluded from the study, as the intervention is based on auditory stimulation through shared reading;
- the caregiver has cognitive impairments or under legal guardianship;
- the caregiver is unable to speak;
- the infant is under foster care at the time of enrollment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kontrolgruppe
|
|
|
Eksperimentel: Intervention Group
Receive additional information on the benefits of reading to your infant.
They will be instructed to participate in a minimum of 3 structured reading sessions and how to log each session.
|
The intervention consists of the following content:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Infant heart rate
Tidsramme: Baseline (at start of the intervention), 2 minutes into the intervention
|
Heart rate, will be abstracted from medical record review.
Heart rate will be measured by the number of beats the infant's heart has per minute.
|
Baseline (at start of the intervention), 2 minutes into the intervention
|
|
Change in Infant heart rate
Tidsramme: Baseline (at start of the intervention),15 minutes after the intervention
|
Heart rate, will be abstracted from medical record review.
Heart rate will be measured by the number of beats the infant's heart has per minute.
|
Baseline (at start of the intervention),15 minutes after the intervention
|
|
Change in Infant Respiratory rate
Tidsramme: Baseline (at start of the intervention), 2 minutes into the intervention
|
Respiratory rate will be abstracted from medical record review.
Respiratory rate will be measured by the number of breaths an infant takes per minute.
|
Baseline (at start of the intervention), 2 minutes into the intervention
|
|
Change in Infant Respiratory rate
Tidsramme: Baseline (at start of the intervention), 15 minutes after the intervention
|
Respiratory rate will be abstracted from medical record review.
Respiratory rate will be measured by the number of breaths an infant takes per minute.
|
Baseline (at start of the intervention), 15 minutes after the intervention
|
|
Change in Infant Oxygen saturation level
Tidsramme: Baseline (at start of the intervention), 2 minutes into the intervention
|
Oxygen saturations level will be abstracted from medical record review.
Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
|
Baseline (at start of the intervention), 2 minutes into the intervention
|
|
Change in Infant Oxygen saturation level
Tidsramme: Baseline (at start of the intervention), 15 minutes after the intervention
|
Oxygen saturations level will be abstracted from medical record review.
Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
|
Baseline (at start of the intervention), 15 minutes after the intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Caregiver Outcome
Tidsramme: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
|
Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
|
Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
14. september 2026
Primær færdiggørelse (Anslået)
14. september 2028
Studieafslutning (Anslået)
15. januar 2029
Datoer for studieregistrering
Først indsendt
4. august 2026
Først indsendt, der opfyldte QC-kriterier
24. august 2026
Først opslået (Faktiske)
27. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STU20252355
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