Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-02 @ 6:23 AM
Study NCT ID:
NCT06631703
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oropharyngeal Colostrum Administration in Premature Infants
Sponsor:
Kocaeli University
Organization:
Study Overview
Official Title:
Effect of Oropharyngeal Colostrum Administration on Early Feeding Skills in Premature Infants
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
this study aimed to determine the effect of oropharyngeal colostrum administration on premature newborns on early feeding cues and transition time to full oral feeding.
Detailed Description:
Breastfeeding has immunologic, nutritional, and neurodevelopmental benefits for premature infants. Follow-up of premature infants in the Neonatal Intensive Care Unit (NICU) for observation and treatment due to immature gestational age, organ or system diseases, and inadequate oral sucking power cause physical and psychological separation of mother and infant, and this is an essential factor leading to breastfeeding failure. Despite the abundant evidence in the literature for the benefits of breast milk and especially colostrum for premature infants, breastfeeding and lactation rates are still very low in this vulnerable population due to poor sucking/swallowing/respiratory coordination.
Although the development of oral feeding skills in premature infants is a challenge for health professionals and parents, oral feeding skills are one of the critical indicators for the discharge of premature infants. Although motor activities such as sucking, swallowing, and breathing are known to be present in the prenatal period, it is not known precisely when this coordination is achieved at the earliest after birth. Approximately 40% of premature infants have difficulty transitioning from enteral to oral feeding. A systematic review showed that premature infants experience problems with oral feeding in the first four years of life, with a prevalence of 42%. Physiological intervention methods that support the transition of premature infants to oral feeding include non-nutritive sucking, oral-motor stimulation, and oral care with colostrum or breast milk. Oropharyngeal colostrum administration is an intervention method reported to activate the digestive hormones of minimal enteral feeding, encourage feeding, accelerate the maturation of the gastrointestinal system, and shorten the transition to full oral feeding with positive stimulation. When the literature is examined, it is reported that premature infants fed with colostrum from the NICU also have increased breastfeeding continuity after discharge. The most crucial difference between our study and the studies available in the literature is related to how oropharyngeal administered colostrum affects the infant's early feeding cues (coordination of sucking-swallowing and respiration during feeding) and how much it accelerates/shortens the transition to oral feeding. In the literature, no study is similar to our study examining how oropharyngeal colostrum administration affects this process in the transition to full oral feeding using a measurement tool on the subject.
Although the development of oral feeding skills in premature infants is a challenge for health professionals and parents, oral feeding skills are one of the critical indicators for the discharge of premature infants. Although motor activities such as sucking, swallowing, and breathing are known to be present in the prenatal period, it is not known precisely when this coordination is achieved at the earliest after birth. Approximately 40% of premature infants have difficulty transitioning from enteral to oral feeding. A systematic review showed that premature infants experience problems with oral feeding in the first four years of life, with a prevalence of 42%. Physiological intervention methods that support the transition of premature infants to oral feeding include non-nutritive sucking, oral-motor stimulation, and oral care with colostrum or breast milk. Oropharyngeal colostrum administration is an intervention method reported to activate the digestive hormones of minimal enteral feeding, encourage feeding, accelerate the maturation of the gastrointestinal system, and shorten the transition to full oral feeding with positive stimulation. When the literature is examined, it is reported that premature infants fed with colostrum from the NICU also have increased breastfeeding continuity after discharge. The most crucial difference between our study and the studies available in the literature is related to how oropharyngeal administered colostrum affects the infant's early feeding cues (coordination of sucking-swallowing and respiration during feeding) and how much it accelerates/shortens the transition to oral feeding. In the literature, no study is similar to our study examining how oropharyngeal colostrum administration affects this process in the transition to full oral feeding using a measurement tool on the subject.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Kocaeli University | OTHER | Kocaeli University | View |