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Completed

NCT Number: NCT05087043

Effects of Oral Stimulation and Supplemental Nursing System

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gonca Muslu

Fethiye, Muğla, 48300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. transition times to oral feeding

    Time frame: 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.

  2. transition times to full breast

    Time frame: 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

  3. the weight of the babies when they started oral nutrition

    Time frame: up to three weeks

    . The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.

  4. the weight of the babies when they started full breastfeeding

    Time frame: 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

  5. the duration of the baby's discharge

    Time frame: 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

  6. The oral nutrition body weight

    Time frame: up to three weeks

    The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.

  7. The full breastfeeding body weight

    Time frame: 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.

  8. The discharge body weight

    Time frame: up to 2 months

    The discharge body weight is the weight in grams of preterm babies at discharge

  9. The sucking success

    Time frame: In the first month after discharge

    The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.

Secondary outcomes

  1. Heart rate of the babies

    Time frame: 15 minutes

    Heart rate

  2. respiratory rate of the babies

    Time frame: 15 minutes

    respiratory rate

  3. oxygen saturation of the babies

    Time frame: 15 minutes

    oxygen saturation

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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