An interventional study of phrenectomy and Increased lactation support in Ankyloglossia, Breast Feeding, Exclusive and Lactation Failure, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Withdrawn at 1 site in Poland. Open to participants aged 1 Minute to 48 Hours. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Not applicable, Interventional, and Prevention
The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.
The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding > 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
Browse Ankyloglossia studies →Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function.
Procedure: phrenectomy
Management in group 2 will include increased lactation care both during hospital stay and post discharge. Increased lactation care will consist of: individual consultations on how to properly attach the baby to the breast (at least 3 meetings during hospitalization with personnel trained in lactation counselling), regular (at least once a week) contact with a breastfeeding consultant as part of a closed group on social media or by phone, if necessary (expressed by the mother or based on a referral by a member of the lactation team) an outpatient appointment at the breastfeeding clinic.
Other: Increased lactation support
The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function (2).
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Also known as: dedicated lactation support
Proportion of exclusively breastfeeding mothers
Proportion of exclusively breastfeeding mothers
Time frame: at 12 weeks of age
Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.
Proportion of mother-baby dyads with a breastfeeding frequency of \> 50% of feedings, which will be assessed using the Breastfeeding Self-Efficacy Scale Short Form \[9, 10\]
Time frame: at 12 weeks of age
Weight change
Median weight change
Time frame: at 12 weeks of age
Head circumference change
Median head circumference change
Time frame: at 12 weeks of age
Length change
Median length change
Time frame: at 12 weeks of age
Incidence of using a breast pump or lactation accessories
Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)
Time frame: at 12 weeks of age
Time of breastfeeding cessation
median time of breastfeeding cessation
Time frame: during 12 weeks of age
Rate of additional consultations
Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.
Time frame: during 12 weeks of age
Change in breastfeeding comfort
Proportion of mothers reporting change in breastfeeding comfort
Time frame: at 12 weeks of age
Plan to share: Undecided
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This study is withdrawn, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Princess Anna Mazowiecka Hospital, Warsaw, Poland