The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
24 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
120
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Kontrollgrupp
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Experimentell: 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.
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The intervention consists of the following content:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Infant heart rate
Tidsram: 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.
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Baseline (at start of the intervention), 2 minutes into the intervention
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Change in Infant heart rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Caregiver Outcome
Tidsram: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
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Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
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Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
14 september 2026
Primärt slutförande (Beräknad)
14 september 2028
Avslutad studie (Beräknad)
15 januari 2029
Studieregistreringsdatum
Först inskickad
4 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
24 augusti 2026
Första postat (Faktisk)
27 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU20252355
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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