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Effects of Oral Stimulation and Supplemental Nursing System

8. oktober 2021 opdateret af: Gonca Karayagiz Muslu, Muğla Sıtkı Koçman University

Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.

Studieoversigt

Detaljeret beskrivelse

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Muğla
      • Fethiye, Muğla, Kalkun, 48300
        • Gonca Muslu

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

1 dag til 4 uger (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • a birth weight of 1,000 gr and above,
  • a gestational age between 30 and 34 weeks,
  • no congenital anomaly,
  • no severe asphyxia or chronic lung disease,
  • spontaneous breathing,
  • grades III and IV intracranial hemorrhage and no periventricular leukomalacia

exclusion criteria.

  • congenital anomaly
  • grades III and IV intracranial hemorrhage and periventricular leukomalacia

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Oral Stimulation and Supplemental Nursing System group
Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group.
OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.
Ingen indgriben: control group
The clinic's routine feeding protocol was applied to the babies in the control group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
transition times to oral feeding
Tidsramme: up to three weeks
Transition time to oral feeding is the time that the preterm baby outgrew gavage feeding and fed with complementary nutritional support, and it was evaluated as days in the study.
up to three weeks
transition times to full breast
Tidsramme: up to 15 days
The transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding
up to 15 days
the weight of the babies when they started oral nutrition
Tidsramme: up to three weeks
. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
up to three weeks
the weight of the babies when they started full breastfeeding
Tidsramme: up to 15 days
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone
up to 15 days
the duration of the baby's discharge
Tidsramme: up to 2 months
The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge
up to 2 months
The oral nutrition body weight
Tidsramme: up to three weeks
The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
up to three weeks
The full breastfeeding body weight
Tidsramme: up to 15 days
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.
up to 15 days
The discharge body weight
Tidsramme: up to 2 months
The discharge body weight is the weight in grams of preterm babies at discharge
up to 2 months
The sucking success
Tidsramme: In the first month after discharge
The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.
In the first month after discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate of the babies
Tidsramme: 15 minutes
Heart rate
15 minutes
respiratory rate of the babies
Tidsramme: 15 minutes
respiratory rate
15 minutes
oxygen saturation of the babies
Tidsramme: 15 minutes
oxygen saturation
15 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: gonca muslu, Muğla Sıtkı Koçman University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2018

Primær færdiggørelse (Faktiske)

15. juni 2018

Studieafslutning (Faktiske)

15. juni 2018

Datoer for studieregistrering

Først indsendt

15. september 2021

Først indsendt, der opfyldte QC-kriterier

8. oktober 2021

Først opslået (Faktiske)

21. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Oral motor stimulation (OMS) and The supplemental nursing system (SNS)

3
Abonner