Oropharyngeal Colostrum Administration in Premature Infants

Not Applicable

Completed

• Conditions: Oral Colostrum Administration; Early Feeding Skills; Transition to Oral Feeding
• Interventions: Other: Group receiving Oral Colostrum Administiration

• Registration Number: NCT06631703
• Lead Sponsor: Kocaeli University

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.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-06
• Last Update Submitted: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The gestational week at the time of delivery is between 260-33+6 gestational weeks, determined according to the mother's last menstrual date and obstetric evaluation results.
• Started feeding with an orogastric catheter, in the process of transition from catheter feeding to oral feeding
• Meeting early feeding readiness criteria (stable respiration and oxygen saturation during feeding, responsiveness to perioral/oral stimulation and licking, etc.)
• 750 g or more during the study
• Stable vital signs (respiratory rate <60/min, heart rate 140-185 beats/min, axillary temperature 36.5-37.4°C) (Acunaş et al., 2018)
• NICU admission ≤ 24 hours of life; protocol can be started within 72 hours,
• No muscle relaxants, sedatives, or severe neurological disease
• Allowing parents of premature infants

Exclusion Criteria

• Congenital or chromosomal anomalies, lack of cardiorespiratory stabilization, birth asphyxia (cord ph/arterial ph <7. 0), twin or more multiple births, intrauterine growth retardation, necrotizing enterocolitis, pneumothorax, skull fracture, severe atelectasis, circulatory disorder, severe sepsis, having a chest tube, having a history of pathologic jaundice, having a history of antenatal gastrointestinal system disease, born with cleft palate/lip, born to mothers with confirmed chorioamnionitis were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group receiving Oral Colostrum Administiration	Group receiving Oral Colostrum Administiration	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.

Primary Outcome Measures

Name	Time	Method
Early Feeding Skills Assessment	10 days	Evaluation will begin with oral colostrum administration to premature infants. The tool allows the assessment of preterm infants' readiness for oral feeding and oral feeding skills, the observation of symptoms associated with problem feeding, and the planning of feeding interventions targeting areas where the infant has difficulty or needs support during the transition to oral feeding. Both the revised EFS and the Turkish version of the EFS include 19 items in 5 subscales. These subscales are respiratory regulation, oral-motor function, swallowing coordination, feeding participation, and physiological stability.

Secondary Outcome Measures

Name	Time	Method
Full oral feeding time	20 days	The days of transition to full oral feeding of the babies in the experimental and control groups will be evaluated throughout the application.
Weight gain	10 days	The weight gain processes of the babies in the experimental and control groups will be evaluated throughout the application with the scales used in the hospital.

Trial Locations

Locations (1)

Sümeyra Topal; 🇹🇷 Kahramanmaras, Dulkadiroğlu, Turkey