CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
Colostrumbiological
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06869902
NCT06869902N/ACompleted

Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomy: A Prospective, Randomized Clinical Trial

Parc de Salut Mar·interventional·Posted Mar 11, 2025·Updated Mar 11, 2025

In Brief

A clinical study evaluating Colostrum for Pain and 2 related conditions. Completed, enrolled 142 participants across 1 site.

Detailed Summary

Neonatal pain must be treated because it may have long-term negative effects. Frenotomy (clipping the tongue-tie) is a painful procedure where common strategies to relieve pain (give oral sucrose, let the baby suck, etc) cannot be used because the technique is performed on the tongue. Inhaling lavender essential oil (LEO) helps treat pain during painful procedures such as blood sampling, vaccination, and frenotomy. We aimed to determine whether smelling colostrum had similar effects as inhaled LEO during frenotomies. We conducted a prospective, randomized clinical trial between September 2023 and June 2024 and evaluated babies who underwent a frenotomy. We assessed pain using the NIPS score, heart rate, oxygen saturation, and crying time. After obtaining parental informed consent, we randomized patients into experimental and control groups. In both groups, we performed swaddling, administered oral sucrose, and let the newborn suck for 2 minutes. In the experimental group, we placed a gauze pad with two drops of colostrum, whereas in the control group, we used one drop of LEO 2 cm under the neonate's nose prior to and during the frenotomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 11, 2025
Enrollment StartSep 18, 2023
Primary CompletionJun 14, 2024
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 1.3 years ago

Interventions

Colostrumbiological

Use of the patient's mother's inhaled colostrum during the frenotomy