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临床试验/NCT05843279
NCT05843279已完成不适用

Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties

Universidad de Almeria1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Latch Scale

研究概览

简要总结

The objective of this randomized, single-blind clinical trial is to compare the efficacy of two treatments (Myofunctional Therapy and breastfeeding sessions) in infants who have difficulty breastfeeding during the first week of life.

The main questions to be answered are:

  • Is breastfeeding improved with this type of intervention?
  • What type of intervention is better?
  • After carrying out these interventions, does the baby need to undergo surgery if it presents a sublingual frenulum? Participants must be infants who are one week old and who have been diagnosed with ankyloglossia through the Hazelbaker Scale. They will be randomly distributed into the two intervention groups and after one month of treatment, they will be assessed again using the same scale.

The researchers will compare the results between these two groups in order to verify the best intervention.

详细描述

Infants who met the inclusion and exclusion criteria, respectively, were accepted to participate in the study. The randomization of the sample was performed by a statistician, who had no prior contact with either the infants or the parents. The online Randomizer (www.randomizer.org) program was used to randomly generate 200 sets of numbers, each containing two numbers ranging from 1 to 2 in random order. After signing the consent, a code was randomly chosen for each patient, thus ensuring that the 200 patients were equally distributed into two groups according to the group number of each code: group 1 (Myofunctional Therapy group) and group 2 (group sessions lactation).

Infants who met the inclusion criteria were referred to the rehabilitation and physiotherapy service. A physical therapist outside the study was in charge of evaluating the measurements of all infants during the first week of life through all the scales detailed below (pre-test). After randomly assigning the infants, another physiotherapist was responsible for applying the intervention once a week for 30 minutes for a period of 30 days. Once the intervention was finished, all the infants (both intervention groups) were reassessed by the physiotherapist outside the study using the same baseline scales (post-test).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

A physiotherapist outside the study was in charge of carrying out the first evaluation in the first week of life of the infant. Another physiotherapist was in charge of applying the physiotherapy intervention. After completion of the intervention, all infants were reassessed by another physiotherapist outside the study.

入排标准

年龄范围
7 Days 至 31 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Full-term infants exclusively breastfed
  • Born both by normal delivery and by cesarean section
  • Who presented difficulty in breastfeeding

排除标准

  • Preterm newborns
  • With low birth weight (less than 2,500 kg)
  • Mothers with flat or inverted nipples
  • Patients who did not wish and did not authorize to participate in the study.

结局指标

主要结局

Latch Scale

时间窗: one month

It is made up of different areas of assessment: how the baby latches on, amount of audible swallowing, type/condition of the mother's nipple, mother's comfort level, and amount of help the mother needs to latch on. baby at the breast The rating system is 0/1/2 in each item (0 equals the "least favourable" and 2 the "most favourable"). The highest score is 10, which means that there is no problem in breastfeeding. If the score is less than 9, it means that the mother and baby need help with breastfeeding.

Hazelbaker scale

时间窗: one month

This scale evaluates the appearance (5 items) and the function of the language (7 items). Each item is scored on a 2/1/0 scale (2 equals good appearance and/or full function; 1 equals moderate appearance and/or partial function; 0 equals no appearance and inadequate function). The maximum appearance score is 10, indicating that there are no limitations in the orofacial structures, and if it is less than 8, a limitation is confirmed. The maximum function score is 14, which reflects preserved function and if it is less than 11, the function is considered to be diminished.

次要结局

  • Surgical intervention after treatment(one month)
  • Visual Analogue Scale(one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gemma María López Segura

Principal Investigator

Universidad de Almeria

研究点 (1)

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