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NICU Parent Education Program (NICU PEP)

2 mai 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Rhode Island
  - Providence, Rhode Island, États-Unis, 02903
    - Women and Infants' Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 mois à 7 mois (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: La prévention
Répartition: Randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Double

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Expérimental: 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).	Autre: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Autre: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Autre: Sing A Long Language Curriculum Early language activity that parents can do with their infants Autre: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Autre: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Comparateur 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.	Autre: Feeding Safety Part of Health and Safety Curriculum Autre: Car Seat Safety Part of Health and Safety Curriculum Autre: Bath Safety Part of Health and Safety Curriculum Autre: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Autre: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Autre: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Groupe de participants / Bras

Intervention / Traitement

Expérimental: 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).

Autre: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Autre: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Autre: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Autre: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Autre: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Comparateur 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.

Autre: Feeding Safety