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NICU Parent Education Program (NICU PEP)

2. mai 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Rhode Island
  - Providence, Rhode Island, Forente stater, 02903
    - Women and Infants' Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 måneder til 7 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Forebygging
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: 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).	Annen: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Annen: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Annen: Sing A Long Language Curriculum Early language activity that parents can do with their infants Annen: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Annen: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Placebo komparator: 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.	Annen: Feeding Safety Part of Health and Safety Curriculum Annen: Car Seat Safety Part of Health and Safety Curriculum Annen: Bath Safety Part of Health and Safety Curriculum Annen: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Annen: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Annen: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Deltakergruppe / Arm

Intervensjon / Behandling

Eksperimentell: 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).

Annen: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Annen: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Annen: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Annen: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Annen: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Placebo komparator: 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.

Annen: Feeding Safety