Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

NICU Parent Education Program (NICU PEP)

2 maggio 2022 aggiornato da: Elisabeth McGowan, Women and Infants Hospital of Rhode Island

The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age.

The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims.

Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure.
Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Rhode Island
  - Providence, Rhode Island, Stati Uniti, 02903
    - Women and Infants' Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 mesi a 7 mesi (Bambino)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Receiving care at Women & Infants' Hospital NICU,
Providence RI gestational age 23 - 32 weeks,
RI resident

Exclusion Criteria:

Unable to understand or speak English,
congenital or chromosomal disorder likely to affect cognitive or speech development,
parental loss of custody

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Language Curriculum The Language Intervention group will receive some of the known methods for early language development. Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day. Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA).	Altro: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Altro: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Altro: Sing A Long Language Curriculum Early language activity that parents can do with their infants Altro: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Altro: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Comparatore placebo: Health and Safety Curriculum Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information. Parents will receive LENA feedback at discharge from NICU.	Altro: Feeding Safety Part of Health and Safety Curriculum Altro: Car Seat Safety Part of Health and Safety Curriculum Altro: Bath Safety Part of Health and Safety Curriculum Altro: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Altro: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Altro: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: Language Curriculum

The Language Intervention group will receive some of the known methods for early language development. Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day. Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA).

Altro: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Altro: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Altro: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Altro: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Altro: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Comparatore placebo: Health and Safety Curriculum

Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information. Parents will receive LENA feedback at discharge from NICU.

Altro: Feeding Safety