Clinical Trials Directory

Trials / Completed

CompletedNCT06631703

Oropharyngeal Colostrum Administration in Premature Infants

Effect of Oropharyngeal Colostrum Administration On Early Feeding Skills in Premature Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Kocaeli University · Academic / Other
Sex
All
Age
26 Weeks – 33 Weeks
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGroup receiving Oral Colostrum AdministirationDescription: Colostrum secreted in the first 3-5 days was oropharyngeal administered to the intervention group by withdrawing 0.2 ml of colostrum to be taken from the mother with the help of an insulin injector every three hours before each feeding meal in accordance with the literature.In the premature infants in the intervention group in which oropharyngeal colostrum was administered, the application was performed as follows: The oropharyngeal colostrum administration technique consists of slowly inserting a sterile 1 mL syringe without a needle with the tip of the syringe into the baby's mouth along the right buccal mucosa (0.1 mL) towards the oropharynx, then moving the syringe towards the inside of the cheeks and on the tongue, and repeating the same procedure on the left buccal mucosa (0.1 mL) without removing it (slow administration in approximately 1 minute). The routine feeding procedure was then continued

Timeline

Start date
2023-12-01
Primary completion
2024-03-01
Completion
2024-06-01
First posted
2024-10-08
Last updated
2024-10-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06631703. Inclusion in this directory is not an endorsement.