Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

NICU Parent Education Program (NICU PEP)

2 maj 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

Fas

Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Rhode Island
  - Providence, Rhode Island, Förenta staterna, 02903
    - Women and Infants' Hospital

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

5 månader till 7 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Förebyggande
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Dubbel

Antal vapen

Vapen och interventioner

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

Deltagargrupp / Arm

Intervention / Behandling

Experimentell: 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).

Övrig: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Övrig: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Övrig: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Övrig: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Övrig: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Placebo-jämförare: 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.

Övrig: Feeding Safety