Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06869902
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2025-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072676', 'term': 'Ankyloglossia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-05', 'size': 154496, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-05T14:32', 'hasProtocol': True}, {'date': '2023-09-05', 'size': 300534, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-05T14:34', 'hasProtocol': False}, {'date': '2023-09-05', 'size': 146933, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-05T14:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A blinded observer assessed pain by means of the Neonatal Infant Pain Scale (NIPS) score, crying duration, and whether there was a change in heart rate (HR) and/or in oxygen saturation (satO2) before and after the procedure.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in heart rate', 'timeFrame': 'Immediately before the technique and up to 5 minutes after completing it', 'description': 'Increase in heart rate before and after the procedure'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Immediately before the technique and up to 5 minutes after completing it', 'description': 'Decrease in oxygen saturation before and after the procedure'}, {'measure': 'NIPS score', 'timeFrame': 'Immediately before the technique and up to 5 minutes after completing it', 'description': 'Assessment of the highest Neonatal Infant Pain Scale (NIPS) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankyloglossia', 'lavender', 'colostrum', 'pain'], 'conditions': ['Pain', 'Ankyloglossia', 'Neonate']}, 'referencesModule': {'references': [{'pmid': '15629985', 'type': 'BACKGROUND', 'citation': 'Marlier L, Gaugler C, Messer J. Olfactory stimulation prevents apnea in premature newborns. Pediatrics. 2005 Jan;115(1):83-8. doi: 10.1542/peds.2004-0865.'}, {'pmid': '30915309', 'type': 'BACKGROUND', 'citation': 'Vaziri F, Khosropoor M, Hidari M, Pourahmad S, Morshed Behbahani B, Saki F. The Effect of Aromatherapy by Lavender Oil on Infant Vaccination Pain: a Double Blind Randomized Controlled Trial. J Caring Sci. 2019 Mar 1;8(1):17-21. doi: 10.15171/jcs.2019.003. eCollection 2019 Mar.'}, {'pmid': '22435980', 'type': 'BACKGROUND', 'citation': 'Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.'}, {'pmid': '11033651', 'type': 'BACKGROUND', 'citation': 'Burns E, Blamey C, Ersser SJ, Lloyd AJ, Barnetson L. The use of aromatherapy in intrapartum midwifery practice an observational study. Complement Ther Nurs Midwifery. 2000 Feb;6(1):33-4. doi: 10.1054/ctnm.1999.0901.'}, {'pmid': '21213523', 'type': 'BACKGROUND', 'citation': 'Habanananda T. Non-pharmacological pain relief in labour. J Med Assoc Thai. 2004 Oct;87 Suppl 3:S194-202.'}, {'pmid': '28579958', 'type': 'BACKGROUND', 'citation': 'Lopez V, Nielsen B, Solas M, Ramirez MJ, Jager AK. Exploring Pharmacological Mechanisms of Lavender (Lavandula angustifolia) Essential Oil on Central Nervous System Targets. Front Pharmacol. 2017 May 19;8:280. doi: 10.3389/fphar.2017.00280. eCollection 2017.'}, {'pmid': '27315487', 'type': 'BACKGROUND', 'citation': "Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17."}, {'pmid': '12555281', 'type': 'BACKGROUND', 'citation': 'Goubet N, Rattaz C, Pierrat V, Bullinger A, Lequien P. Olfactory experience mediates response to pain in preterm newborns. Dev Psychobiol. 2003 Mar;42(2):171-80. doi: 10.1002/dev.10085.'}, {'pmid': '27986905', 'type': 'BACKGROUND', 'citation': 'Harrison D, Larocque C, Bueno M, Stokes Y, Turner L, Hutton B, Stevens B. Sweet Solutions to Reduce Procedural Pain in Neonates: A Meta-analysis. Pediatrics. 2017 Jan;139(1):e20160955. doi: 10.1542/peds.2016-0955. Epub 2016 Dec 16.'}, {'pmid': '11773803', 'type': 'BACKGROUND', 'citation': 'Blass EM, Miller LW. Effects of colostrum in newborn humans: dissociation between analgesic and cardiac effects. J Dev Behav Pediatr. 2001 Dec;22(6):385-90. doi: 10.1097/00004703-200112000-00006.'}, {'pmid': '11474143', 'type': 'BACKGROUND', 'citation': 'Bellieni CV, Buonocore G, Nenci A, Franci N, Cordelli DM, Bagnoli F. Sensorial saturation: an effective analgesic tool for heel-prick in preterm infants: a prospective randomized trial. Biol Neonate. 2001 Jul;80(1):15-8. doi: 10.1159/000047113.'}, {'pmid': '11919330', 'type': 'BACKGROUND', 'citation': 'Bellieni CV, Bagnoli F, Perrone S, Nenci A, Cordelli DM, Fusi M, Ceccarelli S, Buonocore G. Effect of multisensory stimulation on analgesia in term neonates: a randomized controlled trial. Pediatr Res. 2002 Apr;51(4):460-3. doi: 10.1203/00006450-200204000-00010.'}, {'pmid': '12511452', 'type': 'BACKGROUND', 'citation': 'Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.'}, {'pmid': '16082239', 'type': 'BACKGROUND', 'citation': 'Ludington-Hoe SM, Hosseini R, Torowicz DL. Skin-to-skin contact (Kangaroo Care) analgesia for preterm infant heel stick. AACN Clin Issues. 2005 Jul-Sep;16(3):373-87. doi: 10.1097/00044067-200507000-00010.'}, {'pmid': '14609899', 'type': 'BACKGROUND', 'citation': 'Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.'}, {'pmid': '10617751', 'type': 'BACKGROUND', 'citation': 'Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. doi: 10.1542/peds.105.1.e14.'}, {'pmid': '1987534', 'type': 'BACKGROUND', 'citation': 'Blass EM, Hoffmeyer LB. Sucrose as an analgesic for newborn infants. Pediatrics. 1991 Feb;87(2):215-8.'}, {'pmid': '27420164', 'type': 'BACKGROUND', 'citation': 'Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.'}, {'pmid': '8047076', 'type': 'BACKGROUND', 'citation': 'Blass EM, Ciaramitaro V. A new look at some old mechanisms in human newborns: taste and tactile determinants of state, affect, and action. Monogr Soc Res Child Dev. 1994;59(1):I-V, 1-81.'}, {'pmid': '6504620', 'type': 'BACKGROUND', 'citation': 'Field T, Goldson E. Pacifying effects of nonnutritive sucking on term and preterm neonates during heelstick procedures. Pediatrics. 1984 Dec;74(6):1012-5.'}, {'pmid': '33014934', 'type': 'BACKGROUND', 'citation': 'Fitri SYR, Wardhani V, Rakhmawati W, Pahria T, Hendrawati S. Culturally Based Practice in Neonatal Procedural Pain Management: A Mini Review. Front Pediatr. 2020 Sep 3;8:540. doi: 10.3389/fped.2020.00540. eCollection 2020.'}, {'pmid': '32147068', 'type': 'BACKGROUND', 'citation': 'Razaghi N, Aemmi SZ, Sadat Hoseini AS, Boskabadi H, Mohebbi T, Ramezani M. The effectiveness of familiar olfactory stimulation with lavender scent and glucose on the pain of blood sampling in term neonates: A randomized controlled clinical trial. Complement Ther Med. 2020 Mar;49:102289. doi: 10.1016/j.ctim.2019.102289. Epub 2019 Dec 26.'}, {'pmid': '9820568', 'type': 'BACKGROUND', 'citation': 'Franck LS, Lawhon G. Environmental and behavioral strategies to prevent and manage neonatal pain. Semin Perinatol. 1998 Oct;22(5):434-43. doi: 10.1016/s0146-0005(98)80059-1.'}, {'pmid': '14609893', 'type': 'BACKGROUND', 'citation': 'Simons SH, van Dijk M, Anand KS, Roofthooft D, van Lingen RA, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1058-64. doi: 10.1001/archpedi.157.11.1058.'}, {'pmid': '18594041', 'type': 'BACKGROUND', 'citation': 'Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.'}, {'pmid': '12391738', 'type': 'BACKGROUND', 'citation': 'Mitchell A, Boss BJ. Adverse effects of pain on the nervous systems of newborns and young children: a review of the literature. J Neurosci Nurs. 2002 Oct;34(5):228-36. doi: 10.1097/01376517-200210000-00002.'}, {'pmid': '22059203', 'type': 'BACKGROUND', 'citation': 'Johnston C. Pain control in infants and young children. Pain Res Manag. 2011 Sep-Oct;16(5):320. doi: 10.1155/2011/505039. No abstract available.'}, {'pmid': '18053656', 'type': 'RESULT', 'citation': 'Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.'}, {'pmid': '15827459', 'type': 'RESULT', 'citation': 'Rattaz C, Goubet N, Bullinger A. The calming effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2005 Apr;26(2):86-92. doi: 10.1097/00004703-200504000-00003.'}, {'pmid': '21054600', 'type': 'RESULT', 'citation': 'Yilmaz F, Arikan D. The effects of various interventions to newborns on pain and duration of crying. J Clin Nurs. 2011 Apr;20(7-8):1008-17. doi: 10.1111/j.1365-2702.2010.03356.x. Epub 2010 Nov 5.'}, {'pmid': '26560183', 'type': 'RESULT', 'citation': "Neshat H, Jebreili M, Seyyedrasouli A, Ghojazade M, Hosseini MB, Hamishehkar H. Effects of Breast Milk and Vanilla Odors on Premature Neonate's Heart Rate and Blood Oxygen Saturation During and After Venipuncture. Pediatr Neonatol. 2016 Jun;57(3):225-31. doi: 10.1016/j.pedneo.2015.09.004. Epub 2015 Oct 20."}, {'pmid': '8413140', 'type': 'RESULT', 'citation': 'Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.'}, {'pmid': '39141691', 'type': 'RESULT', 'citation': 'Karadede H, Mutlu B. The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates: A Randomized Controlled Trial. Adv Neonatal Care. 2024 Oct 1;24(5):466-474. doi: 10.1097/ANC.0000000000001190. Epub 2024 Aug 27.'}, {'pmid': '19010360', 'type': 'RESULT', 'citation': 'Nishitani S, Miyamura T, Tagawa M, Sumi M, Takase R, Doi H, Moriuchi H, Shinohara K. The calming effect of a maternal breast milk odor on the human newborn infant. Neurosci Res. 2009 Jan;63(1):66-71. doi: 10.1016/j.neures.2008.10.007. Epub 2008 Nov 1.'}, {'pmid': '36076107', 'type': 'RESULT', 'citation': 'Maya-Enero S, Fabregas-Mitjans M, Llufriu-Marques RM, Candel-Pau J, Garcia-Garcia J, Lopez-Vilchez MA. Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824). Eur J Pediatr. 2022 Nov;181(11):3923-3929. doi: 10.1007/s00431-022-04608-3. Epub 2022 Sep 8.'}, {'pmid': '35377106', 'type': 'RESULT', 'citation': 'Maya-Enero S, Fabregas-Mitjans M, Llufriu-Marques RM, Candel-Pau J, Garcia-Garcia J, Lopez-Vilchez MA. Analgesic effect of inhaled lavender essential oil for frenotomy in healthy neonates: a randomized clinical trial. World J Pediatr. 2022 Jun;18(6):398-403. doi: 10.1007/s12519-022-00531-7. Epub 2022 Apr 4.'}, {'pmid': '20817247', 'type': 'RESULT', 'citation': 'Slater R, Cornelissen L, Fabrizi L, Patten D, Yoxen J, Worley A, Boyd S, Meek J, Fitzgerald M. Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial. Lancet. 2010 Oct 9;376(9748):1225-32. doi: 10.1016/S0140-6736(10)61303-7.'}, {'pmid': '9950311', 'type': 'RESULT', 'citation': 'Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Turkuner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. doi: 10.1007/s004310051011.'}, {'pmid': '17565285', 'type': 'RESULT', 'citation': 'Goubet N, Strasbaugh K, Chesney J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2007 Jun;28(3):189-94. doi: 10.1097/dbp.0b013e31802d0b8d.'}, {'pmid': '26685099', 'type': 'RESULT', 'citation': 'Leng HY, Zheng XL, Zhang XH, He HY, Tu GF, Fu Q, Shi SN, Yan L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur J Pain. 2016 Jul;20(6):989-97. doi: 10.1002/ejp.824. Epub 2015 Dec 18.'}, {'pmid': '21028915', 'type': 'RESULT', 'citation': 'Walter-Nicolet E, Annequin D, Biran V, Mitanchez D, Tourniaire B. Pain management in newborns: from prevention to treatment. Paediatr Drugs. 2010 Dec 1;12(6):353-65. doi: 10.2165/11318900-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "We conducted a prospective, randomized clinical trial. Our hospital Ethics Committee (CEIm-PSMAR) approved this study (reference code: 2023/10996). Prior to patient enrollment we obtained a signed informed consent from the neonate's parents. This study was conducted according to the ethics code of the Barcelona Medical Association and the principles of the Helsinki-Fortaleza Declaration 2013, at the neonatal unit of a tertiary care hospital in Barcelona (Spain) within an area of influence of approximately 400,000 people, which experiences approximately 1,400 births per year. The target population for this study, and thus, inclusion criteria were healthy full-term neonates born at our center or less than 15 days old referred for a frenotomy, who had ankyloglossia according to the Hazelbaker tool between September 2023 and June 2024. We assess for the presence of ankyloglossia as part of the routine neonatal evaluation using the Hazelbaker tool to evaluate its impact on tongue movement and on breastfeeding. According to the Hazelbaker tool, ankyloglossia exists if appearance scores 8 points or less and/or function scores 11 points or less. We offer a frenotomy to all patients with ankyloglossia. During the study period, if we identified a patient with ankyloglossia, we offered the patient's parents the opportunity to participate in this study.\n\nPatients were enrolled if their parents agreed to and signed a written informed consent. We only included patients who were breastfed, as after randomization we may need to get colostrum. Enrolled patients were randomized into case or control group by simple random sampling using sequentially numbered containers. During the frenotomy the neonate was taken to the neonatal unit and monitored with a pulse-oximeter (COVIDIEN Nellcor Portable SpO2 Patient Monitoring System PM10N, Covidien Ireland Limited, IDA Business \\& Technology Park, Tullamore, Ireland) before, during and after the procedure. For both groups we swaddled, administered 1 mL of oral sucrose, and let the newborn suck for 2 minutes prior to the procedure. The control group had a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) placed 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure, whereas the experimental group had a gauze with 2 drops of colostrum of the patient's mother placed in the same way. We used two drops of colostrum but only one of LEO because the odor of colostrum is more subtle than that of LEO, and in our previous studies \\[32-33\\] we had used one drop of LEO, and that is how we routinely perform frenotomies. Once the procedure was completed, we removed the gauze pad and recorded vital signs, whether the baby cried or not, the seconds crying lasted, and the NIPS score on a data collection sheet. If a neonate cried, calming techniques such as holding, swaddling, and sucking were employed. A blinded observer assessed pain by means of the Neonatal Infant Pain Scale (NIPS) score (Figure 2) \\[40\\], crying duration, and whether there was a change in heart rate (HR) and/or in oxygen saturation (satO2) before and after the procedure.\n\nIn a previously published study where we compared performing frenotomies using complementary analgesia or not with inhaled LEO, we observed a mean (SD) crying time of 14.8 vs 24.6 (10.8 vs 27.6) seconds in favor of LEO \\[32\\]. In order to detect a difference of 10 seconds in crying time, we calculated that we needed a sample size of 71 patients per group in order to draw conclusions with a CI 95% and a power of 80%. We chose to evaluate pain by means of the increase of HR rather than via the NIPS score because in previous research, we obtained NIPS scores of 1.88-2.92 and 2.02-2.38, and a NIPS score less than 3 indicates no pain. We used the NIPS score to assess whether neonates exhibited pain when using inhaled colostrum instead of LEO.\n\nWe recorded demographic (sex, gestational age, birth weight, age in hours at the time of frenotomy) and clinical variables (HR and satO2 before, during, and after the procedure, whether the patient cried or not during the procedure, length of crying time in seconds, presence of side effects during the procedure (apnea, desaturation, others) and highest NIPS score within the first 5 minutes after the procedure). The attending staff were trained to assess the NIPS score before we started recruiting patients. Even though patients were swaddled, it was feasible to feel if they moved their legs or arms. The independent variable was the use of inhaled colostrum or inhaled LEO during frenotomy. The dependent variables were HR and satO2 pre and post procedure, presence of crying and duration, hours of life at the time of the frenotomy, and the NIPS score. The controlled variables were gestational age, sex, and birth weight.\n\nStatistical analysis: Quantitative variables (gestational age, birth weight, age at frenotomy, heart rate pre and post-procedure, increase in heart rate post-procedure, oxygen saturation pre and post-procedure, decrease in oxygen saturation post-procedure, and duration of crying) are described using the mean, standard deviation and range; experimental vs control groups were compared with a Student's t-test. We assessed the equality of variances by using Levene's test and applied the result of the Student's t-test accordingly. Sex, the presence of crying, and adverse effects between the two groups are presented in percentages and compared using Fisher's exact test. Statistical significance was set for a p \\<0.05. To perform statistical analyses we used STATA version 16.1 (StataCorp, College Station, TX, USA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy full-term neonates born at our center or less than 15 days old referred for a frenotomy, who had ankyloglossia according to the Hazelbaker tool who were breastfed\n\nExclusion Criteria:\n\n* Denial of the patient's parents to participate"}, 'identificationModule': {'nctId': 'NCT06869902', 'briefTitle': 'Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomy: A Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2023/10996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Lavender essential oil', 'description': 'Patients were swaddled, were given 1 mL of oral sucrose, and we let them suck for 2 minutes prior to the procedure. We placed a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'Colostrum', 'description': "Patients were swaddled, were given 1 mL of oral sucrose, and we let them suck for 2 minutes prior to the procedure. We placed a 7 x 7 cm gauze pad with 2 drops of their mother's colostrum 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure.", 'interventionNames': ['Biological: Colostrum']}], 'interventions': [{'name': 'Colostrum', 'type': 'BIOLOGICAL', 'description': "Use of the patient's mother's inhaled colostrum during the frenotomy", 'armGroupLabels': ['Colostrum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Silvia Maya-Enero, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}