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NICU Parent Education Program (NICU PEP)

2 maja 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Stany Zjednoczone
- Rhode Island
  - Providence, Rhode Island, Stany Zjednoczone, 02903
    - Women and Infants' Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

5 miesięcy do 7 miesięcy (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Zapobieganie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Podwójnie

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: 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).	Inny: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Inny: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Inny: Sing A Long Language Curriculum Early language activity that parents can do with their infants Inny: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Inny: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Komparator 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.	Inny: Feeding Safety Part of Health and Safety Curriculum Inny: Car Seat Safety Part of Health and Safety Curriculum Inny: Bath Safety Part of Health and Safety Curriculum Inny: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Inny: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Inny: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: 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).

Inny: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Inny: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Inny: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Inny: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Inny: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Komparator 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.

Inny: Feeding Safety