RecruitingACTRN12617000897369

Suck swallow breathe coordination in term breastfed infants with and without oral anomalies.

Infants with ankyloglossia and feeding difficulties: the effect of frenotomy on suck-swallow breathe coordination, intra-oral vacuum, breastfeeding efficiency and duration compared to age-matched infants without ankyloglossia and feeding difficulties.


Sponsor

A/Prof Donna Geddes

Enrollment

60 participants

Start Date

Aug 15, 2016

Study Type

Interventional

Conditions

Summary

Breastfeeding is distinctive to all newborn mammals and provides babies with optimal nutrition, protection from disease and enhanced development. Coordination of sucking swallowing and breathing (SSB) is critical for efficient feeding. The tongue plays major role in infant sucking, facilitating milk removal from the breast and safe swallowing of the milk bolus. Current evidence suggests that SSB coordination in breastfeeding babies with ankyloglossia differs to those without oral anomalies and they are likely to experience breastfeeding difficulties including maintaining attachment at the breast and reduced milk transfer. Further, their mothers may experience nipple pain and trauma that can result in early weaning. Although frenotomy is associated with decreased maternal nipple pain and improved breast attachment, the impact of ankyloglossia and frenotomy on SSB coordination and associated breastfeeding difficulties is not well understood. We aim to compare the following measures in age-matched healthy infants between those without and those with ankyloglossia and breastfeeding difficulties (pre and post frenotomy) 1. Intra-oral vacuum strength, 2. SSB coordination, 3. Tongue movement 4. Milk transfer (total mL) 5. Maternal nipple pain, and breastfeeding confidence 6. Breastfeeding duration We hypothesize that for infants with ankyloglossia more than one component of the SSB coordination will change post frenotomy to be comparable with those of the control group


Eligibility

Sex: Both males and femalesMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how tongue-tie (ankyloglossia) in newborn babies affects breastfeeding and whether a small procedure to release the tongue-tie (called a frenotomy) improves the baby's ability to suck, swallow, and breathe in a coordinated way during feeding. Breastfeeding can be painful and difficult when a baby has tongue-tie. This research will measure suction strength, tongue movement, milk intake, and nipple pain in mothers before and after the procedure. You may be eligible if: - You are an English-speaking mother with a baby under 12 weeks old - Your baby was born at term (37 weeks or later) and weighs at least 2,500g - You intend to breastfeed for at least 6 months - Your baby is being breastfed (formula makes up less than half of feedings) - A health professional has identified tongue-tie and breastfeeding difficulties in your baby You may NOT be eligible if: - You have had breast surgery or nipple piercing - Your baby was born before 37 weeks of pregnancy - Your baby was born weighing less than 2,500g - Your baby has an acute illness, infection, or congenital condition - You have multiple babies (twins, triplets) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Infants with ankyloglossia will attend one study session up to 10 days prior to frenotomy and one study session 14-21 days after frenotomy for monitoring of a breastfeed. A paediatric surgeon will pe

Infants with ankyloglossia will attend one study session up to 10 days prior to frenotomy and one study session 14-21 days after frenotomy for monitoring of a breastfeed. A paediatric surgeon will perform frenotomy, a simple surgical treatment that divides the lingual frenulum. Normally general anaesthesia is not required and some medical practitioners prefer to use a topical anaesthetic; the paediatric surgeon participating in this study does not use general anaesthesia in infants < 6 months (all of our study subjects are < 6 months of age and therefore will not have general anaesthesia). The infant’s tongue is gently lifted with a sterile grooved retractor or index finger to expose the lingual frenulum. An incision is made using sterile iris scissors to divide the frenulum between the tongue and alveolar ridge. The procedure is typically completed within a few minutes. The infant is immediately returned to the mother for a breastfeed. All study infants will be followed up by telephone to 12 months of age.


Locations(1)

King Edward Memorial Hospital - Subiaco

WA, Australia

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ACTRN12617000897369


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