Evaluation of Breastfeeding in Infants with Cleft Palate

Study ID: STU 102017-018

Summary

We intend to undertake a prospective cohort study with two arms. The control arm will consist of 30 infants with a cleft palate (with or without cleft lip). This group will be fed using existing standard of care cleft feeding devices using bottles. The experimental arm will also consist of 30 infants with a cleft palate (with or without cleft lip). These infants will be provided with our cleft breast feeder and trained in its use by our Craniofacial speech and feeding pathologists. The efficacy of the cleft breast feeder will be assessed by tracking the infants' weights and compared both to the control group and to the standard growth curves for the infants' age.

Participant Eligibility

Subjects with a cleft palate with or without cleft lip Mothers who are willing to breastfeed exclusively Willing to attend weight gain clinic at regularly scheduled appointments

Cancer Related: No
Healthy Volunteers: No
UT Southwestern Principal Investigator: JAMES RICHARD SEAWARD

Contact:

Neil Stewart

Neil.Stewart@UTSouthwestern.edu

Cleft palate (with or without cleft lip) is the most common craniofacial anomaly affecting 1 in 700 children in the uSa. This translates into 5,500 babies born with cleft lip and/or palate each year in the uSa and 200,000 worldwide. While some of these children will have cleft lip alone, the majority will have both a cleft lip and a cleft palate. in a complete cleft lip and palate, there is a gap in the skin and muscle of the lip, through the gum line, through the floor of the nose on that side, and through the palate, both the hard palate towards the front of the mouth and the soft palate towards the back of the mouth. The most historical and natural way for babies to feed is by breast feeding. The mechanism for breast feeding is that stimulation of the nipples by the baby suckling signals the brain to release the hormone oxytocin, which causes contraction of the alveoli storing the milk, driving the stored milk through the ducts and out of the nipple into the baby's mouth. This is known as the Milk ejection Reflex (also sometimes called the 'letdown reflex' or 'oxytocin reflex'). The baby stimulates this reflex by compressing the nipple against the roof of the mouth using their tongue. in addition, the baby generates suction within the mouth to further aid milk delivery. in a baby with a cleft palate, there is no intact roof of the mouth to compress the nipple against, so the stimulation to drive the milk ejection reflex is reduced. The baby is also unable to generate suction as any attempt to create a negative pressure in the mouth will result in air entering the mouth through the nose and the cleft. normally, the soft palate would raise and would act as a valve system with the nasopharynx, blocking airflow through the nose so that suction can be created in the mouth but, with a cleft in the palate, the valve system is ineffective. For these reasons, it is unlikely that a baby born with a cleft palate will be able to receive adequate nutrition through breast feeding, and will need a device to help meet nutritive requirements. at present, there are several devices to enable feeding for babies with a cleft palate, but these all attach to a bottle, requiring pumping and storage of milk for the baby to feed using breast milk. Globally, there may not be resources to enable safe pumping and storage of milk. and so many babies born with cleft palate are malnourished. Together with the Handi-Craft Company, manufacturers of the Dr Brown's Baby range of products, we have developed a system to enable babies born with a cleft palate to breast feed directly.