Fitting of Commonly Available Face Masks for Late Preterm and Term Infants

NCT03369028 | Completed

• 1 other identifier: CAFF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face. It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face. A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. A study performed in preterm infants showed that most masks available are too big for the majority of those infants. The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).

Conditions

Face; Newborn; Preterm Infant

Outcome Measures

Primary Outcomes (4)

• Mouth: Find out the best fitting facemask

  Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.

  1 year

• Lips: Find out the best fitting facemask

  Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.

  1 year

• Eyes: Find out the best fitting facemask

  Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.

  1 year

• Chin: Find out the best fitting facemask

  Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.

  1 year

Secondary Outcomes (5)

• Gestational age

  1 year

• Birth weight

  1 year

• headcircumference

  1 year

• gender: male/female

  1 year

• way of delivery: spontaneous/cesarean

  1 year

Study Arms (1)

2d and 3D image

A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.

Other: 2D and 3D image of infants´ faces

Interventions

2D and 3D image of infants´ faces OTHER

2D and 3D image of infants´ faces

2d and 3D image

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

* Late preterm and term infants, gestational week ≥ 34 +0 * 10 to 15 patients in every gestational-week * born at the University Hospital of Tuebingen * signed declaration of consent from the parents * ≤ 72 hours

You may qualify if:

• Late preterm and term infants, gestational week ≥ 34 +0
• born at the University Hospital of Tuebingen
• signed declaration of consent from the parents
• ≤ 72 hours

You may not qualify if:

• congenital facial anomalies
• any respirators or other medical device that covers the face
• missing declaration of consent from the parents

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University clinic tuebingen

Tübingen, 72072, Germany

Location

Related Publications (20)

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  PMID: 28096704 BACKGROUND

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  PMID: 15174776 BACKGROUND

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  PMID: 15871989 BACKGROUND

• Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.

  PMID: 20547584 BACKGROUND

• Cheung D, Mian Q, Cheung PY, O'Reilly M, Aziz K, van Os S, Pichler G, Schmolzer GM. Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial. J Perinatol. 2015 Jul;35(7):464-8. doi: 10.1038/jp.2015.8. Epub 2015 Feb 26.

  PMID: 25719544 BACKGROUND

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  PMID: 28452098 BACKGROUND

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  PMID: 18039750 BACKGROUND

• Wood FE, Morley CJ. Face mask ventilation--the dos and don'ts. Semin Fetal Neonatal Med. 2013 Dec;18(6):344-51. doi: 10.1016/j.siny.2013.08.009. Epub 2013 Sep 14.

  PMID: 24041823 BACKGROUND

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  PMID: 19255015 BACKGROUND

• Deindl P, Schwindt J, Berger A, Schmolzer GM. An instructional video enhanced bag-mask ventilation quality during simulated newborn resuscitation. Acta Paediatr. 2015 Jan;104(1):e20-6. doi: 10.1111/apa.12826. Epub 2014 Oct 30.

  PMID: 25308155 BACKGROUND

• O'Shea JE, Thio M, Owen LS, Wong C, Dawson JA, Davis PG. Measurements from preterm infants to guide face mask size. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F294-8. doi: 10.1136/archdischild-2014-307350. Epub 2015 Apr 10.

  PMID: 25862726 BACKGROUND

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  PMID: 19881369 BACKGROUND

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  PMID: 23348308 BACKGROUND

• Farkas LG. Accuracy of anthropometric measurements: past, present, and future. Cleft Palate Craniofac J. 1996 Jan;33(1):10-8; discussion 19-22. doi: 10.1597/1545-1569_1996_033_0010_aoampp_2.3.co_2.

  PMID: 8849854 BACKGROUND

• Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089.

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• Farkas LG. [Centenary of Ambrus Abraham]. Orv Hetil. 1994 Jun 26;135(26):1429. No abstract available. Hungarian.

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• Haase B, Badinska AM, Maiwald CA, Poets CF, Springer L. Comparison of nostril sizes of newborn infants with outer diameter of endotracheal tubes. BMC Pediatr. 2021 Sep 23;21(1):417. doi: 10.1186/s12887-021-02889-5.

  PMID: 34556062 DERIVED

• Haase B, Badinska AM, Koos B, Poets CF, Lorenz L. Do commonly available round facemasks fit near-term and term infants? Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):364-368. doi: 10.1136/archdischild-2019-317531. Epub 2019 Sep 21.

  PMID: 31542729 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

two-dimensional and three-dimensional images retained, with no potential for DNA extraction from any retained samples. Not working with any part of the body of the investigators´ participants.

MeSH Terms

Conditions

Facies; Premature Birth

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 11, 2017
• Study Start: April 10, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: May 30, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)