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Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil

NCT06869902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Pain
  • Ankyloglossia
  • Neonate

Interventions

BIOLOGICAL

Colostrum

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

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Silvia Maya-Enero, PhD, MD · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-06-14
Completion
2024-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869902 on ClinicalTrials.gov