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临床试验/NCT02952950
NCT02952950已完成不适用

Is it Possible to Prolong the Duration of Exclusive Breastfeeding in Premature Infants? a Prospectivt Study

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
2
主要终点
Duration of Breastfeeding

研究概览

简要总结

In this project three studies examined two possible explanations and one possible preventive intervention to early cessation of exclusively breastfeeding in premature infants.

Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a third higher than in the milk from the mother who delivers on time. The nutritional composition changes over time and the content of protein decrease. Therefore the premature infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing content of protein can made up by adding, while it is more difficult when the infant is exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is associated to a fewer number of days where the premature infant is exclusively breastfed.

Study 2 The premature infant is characterized with immature muscle with a low tension and therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of milk from mother to child is an interaction between the mothers and her milk ejection reflex that establish a positive pressure on the milk and the child that have to establish a vacuum. The hypothesis is that the premature infants suction power is too weak to establish sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can be related to a fewer number of days where the infant is exclusively breastfed.

Study 3 The premature infants low muscle tone and its immaturity also influence on the organization and the quality of movements, marked as neuro motor processes. These processes form the oral motor base supporting movement which involves the infant ability to establish vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to create intra oral vacuum and thus the power to transfer milk from the breast, thereby extending the number of days when the infant is exclusively breastfed.

200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1 the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant suction is assessed by vacuum measurement. In study 3 the families are randomized to an intervention or control group and parents off 100 infants are guided by occupational therapists in a program of oral stimulation of their child.

详细描述

The purpose of this project, which consists of three studies, is to investigate whether insufficient protein in breastmilk and / or inadequate intra oral vacuum of the infant can explain early breastfeeding cessation in the premature infant. Furthermore to test whether the breastfeeding period may be extended by oral stimulation.

The rate of breastfeeding in mothers of infants born prematurely is lower than in mothers who give birth on time. A Danish survey shows that about 70% of premature are on exclusive breastfeeding at discharge and that this rate is decreasing to about 30% six weeks after discharge. Breastmilk is the healthiest nutrition for the newborn and based on WHO's strategy for the feeding of infants Board of Health recommends that newborn infants, including premature, as far as possible are exclusively breastfed for six months. Exclusively breastfeeding means that the infant only gets the breastmilk of the mother. Exclusively breastfeeding has health implications for both mother and infant. Breastfeeding reduces lactation incidence of infectious diseases, improves cognitive development and visual function in the infant and reduces the risk of developing later obesity. In addition, the level of immune protective factors and anti-inflammatory elements is high in the mother's milk to the preterm infant and therefore reduce the infant's increased risk of early and severe infections, and death late effects. Furthermore, breastfeeding may reduce the risk of premature infant's abnormal vessel growth in the eye, and appears to have a protective effect on the disease being of significant excess mortality primarily attack the intestines of the preterm infant (necrotizing enterocolitis).

Problem Area / factors in milk composition with the importance of breastfeeding Breastmilk contains the necessary nutritional components and energy that the infant needs. Therefore, the milk of the mother delivering early have a higher content of fat and protein, and thereby a higher level of energy comparing with the milk from the mother who have given birth to term. The content of protein in the milk of the mother who gives birth prematurely is about 12 grams per liter and thus approximately one-third higher than that from the mother who gives birth on time. The nutritional composition of breastmilk vary considerably over time and the content of protein is decreasing why the premature infant are at risk of protein deficiency and thereby insufficient growth. During the hospital stay, and while the infant are feed by tube this decreasing protein content are made up by adding, while it is more difficult when the infant breastfeed exclusively. Protein is important for the infant's growth and strength and a local statement from Hvidovre Hospital found that 18% of all hospitalized preterm infants in 2014 were added additional protein to breastmilk, because growth was not sufficient. The question is whether reduced protein content in breastmilk has a correlation with the number of days where preterm infants are exclusively breastfed?

Problem Area / intra oral vacuum strength of the infant with significance for breastfeeding The period from birth to the premature infant feed exclusively at the breast without supplementary tube feeding varies from weeks to months, depending on how early the infant is born. The premature infant is characterized as being immature and with low muscle tone and therefore, a decreased ability to breastfeed the first time. The transfer of milk from mother to infant is an interaction between the mother and her milk ejection reflex creates a positive pressure on the milk and the infant creates a vacuum. If the infant not create a vacuum at the back of the mouth, the nipple of the mother is just pushed together and the infant is not transferred milk from the breast to the oral cavity. The amount of milk is regulated in relation to demand and a weak or shortage of vacuum will cause a shortage of milk transfer, which in turn physiologically will lead to less milk production and thereby decreasing amount. Studies that investigates this process and measured intra oral vacuum, shows all the importance of the infant's contribution by milk transfer, but does not answer to the extent the premature infants ability to create vacuum importance of breastfeeding establishment and maintaining. The question is whether the premature infants sucking strength is too weak to establish sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can be related to a fewer number of days where the infant is exclusively breastfed.

In addition to the premature infants muscle tone has its immaturity also affect the organization and quality of body movements. Organization and quality in the movements may be referred to neuro motor processes and form among others the oral motor base supporting the movements involving the infant's ability to create vacuum. The processes preceding the creation of vacuum and studies have shown that by early intervention with oral stimulation in the form of stimulation of the nerves and muscles in and around the mouth, it can be oral motor basis strengthened. Studies where the infant carefully is stimulated with a finger, showing that the premature infant's muscles and sucking reflex can be influenced so that it is able to suck a larger volume in a shorter time in the bottle compared to the infant that is not stimulated orally. This presents an opportunity to influence the premature infant´s strength and maybe increase the ability to create intra oral vacuum affected by oral stimulation as a skill the infant preserves. The question is whether oral stimulation can increase the premature infant's ability to create vacuum and thus increase the power to transfer milk from the breast and thereby extending the number of days when with exclusively breastfed? The 3 studies are based on the same cohort. The cohort is identified and recruited at the Neonatal Intensive Care Unit at Hvidovre Hospital and relevant families where the mother delivers prematurely are included consecutively in accordance to the inclusion and exclusion criteria. The cohort will be demographically representative of everyday life in clinical practice with various family formation, education levels and socio-economic background conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
— 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • mothers: with premature infant i.e. the infant's gestational age is equal to or maximum of 36 + 6
  • intend to breastfeed.
  • The mother or father / other primary caregiver understand Danish, Norwegian, Swedish or English.

排除标准

  • mothers: will not / can´t breastfeed because of illness or abuse such as: HIV and drugs.
  • In addition, if the infant has a disability which makes it difficult to breastfeeding or if the infant is physiologically unstable, for example due to reduced lung function.

研究组 & 干预措施

Oralstimulation

Other

Infants whose mothers is included in the cohort is randomized to receive oral stimulation when the infant's postnatal age is at least 32 + 0 weeks, as it is the time when the infant is able to coordinate sucking and swallowing reflex

干预措施: Oralstimulation (Other)

Controlgroup

No Intervention

Families in the control group is not seeing the oralstimulation movie, do not receive the script or the supervision of occupational therapists and these infants do not get oral stimulation. Both groups receive instructions after usual practice i.e. guidance and elements that promote breastfeeding example, skin to skin contact and compression.

结局指标

主要结局

Duration of Breastfeeding

时间窗: 6 month

Exclusively breastfeeding duration measured in number of whole days and defined as the infant is exclusively fed with breastmilk

次要结局

  • Intra Oral Vacuum(6 weeks after the terminator date)
  • Content of protein in breastmilk(6 weeks after the terminator date)

研究者

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

Diana Skaaning

Principal Investigator

Hvidovre University Hospital

研究点 (2)

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