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NICU Parent Education Program (NICU PEP)

2. maj 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - Women and Infants' Hospital

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

5 måneder til 7 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Antal våben

Våben og indgreb

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

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: 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).

Andet: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Andet: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Andet: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Andet: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Andet: 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.

Andet: Feeding Safety