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Effects of Oral Stimulation and Supplemental Nursing System

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05087043
Enrollment
70
Registered
2021-10-21
Start date
2018-02-01
Completion date
2018-06-15
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

Preterm, oral stimulation, supplemental nursing system

Brief summary

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.

Detailed description

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.

Interventions

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

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.

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The sucking successIn the first month after dischargeThe sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.
The oral nutrition body weightup to three weeksThe oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
The full breastfeeding body weightup to 15 daysThe full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.
The discharge body weightup to 2 monthsThe discharge body weight is the weight in grams of preterm babies at discharge
transition times to oral feedingup to three weeksTransition 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.
transition times to full breastup to 15 daysThe transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding
the weight of the babies when they started oral nutritionup to three weeks. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
the weight of the babies when they started full breastfeedingup to 15 daysThe full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone
the duration of the baby's dischargeup to 2 monthsThe duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge

Secondary

MeasureTime frameDescription
respiratory rate of the babies15 minutesrespiratory rate
oxygen saturation of the babies15 minutesoxygen saturation
Heart rate of the babies15 minutesHeart rate

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026